wikidoc - Recent changes [en]

SANDBOX:HT

2026-05-05T01:55:26Z

Suzetrigene

2026-05-04T21:23:41Z

← Older revision		Revision as of 21:23, 4 May 2026
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	* When JOURNAVX is administered to patients taking moderate CYP3A inhibitors reduce the JOURNAVX dose, as described below:		* When JOURNAVX is administered to patients taking moderate CYP3A inhibitors reduce the JOURNAVX dose, as described below:

	1. Dose 1: The recommended starting dose of JOURNAVX is 100 mg orally. Take the starting dose on an empty stomach at least 1 hour before or 2 hours after food. Clear liquids may be consumed during this time (e.g., water, apple juice, vegetable broth, tea, black coffee).		Dose 1: The recommended starting dose of JOURNAVX is 100 mg orally. Take the starting dose on an empty stomach at least 1 hour before or 2 hours after food. Clear liquids may be consumed during this time (e.g., water, apple juice, vegetable broth, tea, black coffee).
	2. Doses 2, 3, and 4: Starting 12 hours after the initial dose, take 50 mg of JOURNAVX orally every 12 hours. Take these doses with or without food.
	3. Dose 5 and Subsequent Doses: Starting 12 hours after Dose 4, take 50 mg of JOURNAVX orally every 24 hours. Take these dose(s) with or without food.		Doses 2, 3, and 4: Starting 12 hours after the initial dose, take 50 mg of JOURNAVX orally every 12 hours. Take these doses with or without food.
	4. Avoid food or drink containing grapefruit during treatment with JOURNAVX.
			Dose 5 and Subsequent Doses: Starting 12 hours after Dose 4, take 50 mg of JOURNAVX orally every 24 hours. Take these dose(s) with or without food.

			Avoid food or drink containing grapefruit during treatment with JOURNAVX.
	\|warnings=FDA reported warnings and precautions associated with the JOURNAVX are as follows:		\|warnings=FDA reported warnings and precautions associated with the JOURNAVX are as follows:

Suzetrigene

2026-05-04T21:21:39Z

Created page with "{{DrugProjectFormSinglePage |authorTag={{AIJ}} |genericName=JOURNAVX |aOrAn=a |drugClass=sodium channel blocker |indicationType=treatment |indication=of moderate to severe pain acute pain, including postoperative pain, in adults. |adverseReactions=pruritus, muscle spasms, increased creatine phosphokinase, and rash. Add table 2 |blackBoxWarningTitle='''TITLE''' |blackBoxWarningBody=''Condition Name:</span..."

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{{DrugProjectFormSinglePage
|authorTag={{AIJ}}
|genericName=JOURNAVX
|aOrAn=a
|drugClass=sodium channel blocker
|indicationType=treatment
|indication=of moderate to severe pain acute pain, including postoperative pain, in adults.
|adverseReactions=pruritus, muscle spasms, increased creatine phosphokinase, and rash.

Add table 2
|blackBoxWarningTitle='''TITLE'''
|blackBoxWarningBody=''Condition Name:'' There is limited information regarding Black Box Warning of Suzetrigene in adult patients.
|fdaLIADAdult=Adult Indications.
JOURNAVX is indicated for the treatment of moderate to severe acute pain, including postoperative pain, in adults. Use JOURNAVX for the shortest duration, consistent with individual patient treatment goals. Use of JOURNAVX for the treatment of moderate to severe acute pain has not been studied beyond 14 days.

Recommended Dosage and Administration:
* The recommended starting dose of JOURNAVX is 100 mg orally.
* Take the starting dose on an empty stomach at least 1 hour before or 2 hours after food to avoid delay in onset of action.
* Clear liquids may be consumed during this time (e.g., water, apple juice, vegetable broth, tea, black coffee).
* Starting 12 hours after the initial dose, take 50 mg of JOURNAVX orally every 12 hours.
* Avoid food or drink containing grapefruit during treatment with JOURNAVX.

Dosage Form.
* Tablets: 50 mg, blue, film-coated, oblong tablets debossed with "VX50" on one side and plain on the other.

Recommedations regarding Missed Doses.
For patients on the standard recommended dosing schedule:
* If a dose is missed, take the missed dose as soon as possible and then take the next scheduled dose at the recommended time.
* If two or more doses are missed, take 100 mg and then take the next scheduled dose at the recommended time.
|offLabelAdultGuideSupport=There is limited information regarding ''Off-Label Guideline-Supported Use'' of Suzetrigene in adult patients.
|offLabelAdultNoGuideSupport=There is limited information regarding ''Off-Label Non–Guideline-Supported Use'' of Suzetrigene in adult patients.
|fdaLIADPed=There is limited information regarding indications and dosage of Suzetrigene in pediatric patients.
|offLabelPedGuideSupport=There is limited information regarding ''Off-Label Guideline-Supported Use'' of Suzetrigene in pediatric patients.
|offLabelPedNoGuideSupport=There is limited information regarding ''Off-Label Non–Guideline-Supported Use'' of Suzetrigene in pediatric patients.
|contraindications=* JOURNAVX is contraindicated in patients taking strong CYP3A inhibitors.
* When JOURNAVX is administered to patients taking moderate CYP3A inhibitors reduce the JOURNAVX dose, as described below:

1. Dose 1: The recommended starting dose of JOURNAVX is 100 mg orally. Take the starting dose on an empty stomach at least 1 hour before or 2 hours after food. Clear liquids may be consumed during this time (e.g., water, apple juice, vegetable broth, tea, black coffee).
2. Doses 2, 3, and 4: Starting 12 hours after the initial dose, take 50 mg of JOURNAVX orally every 12 hours. Take these doses with or without food.
3. Dose 5 and Subsequent Doses: Starting 12 hours after Dose 4, take 50 mg of JOURNAVX orally every 24 hours. Take these dose(s) with or without food.
4. Avoid food or drink containing grapefruit during treatment with JOURNAVX.
|warnings=FDA reported warnings and precautions associated with the JOURNAVX are as follows:

'''Increased Risk of Adverse Reactions with Concomitant Use with Strong or Moderate CYP3A Inhibitors'''
Strong and moderate CYP3A inhibitors increase suzetrigine and M6-SUZ (active metabolite) exposures which may cause JOURNAVX adverse reactions. Concomitant use of JOURNAVX with strong CYP3A inhibitors is contraindicated. Reduce the JOURNAVX dosage with moderate CYP3A inhibitors.

'''Risk of Drug Interactions with Certain CYP3A Substrates'''
Suzetrigine is an inducer of CYP3A. If JOURNAVX is used concomitantly with sensitive CYP3A substrates or CYP3A substrates where minimal concentration changes may lead to loss of efficacy, refer to the Prescribing Information for the CYP3A substrates for dosing instructions. Dosage adjustment of the concomitant CYP3A substrates may be required when initiating or discontinuing JOURNAVX.

'''Risk of Drug Interactions with Certain Hormonal Contraceptives'''
JOURNAVX-treated patients taking concomitant hormonal contraceptives containing progestins other than levonorgestrel and norethindrone should use additional nonhormonal contraceptives (such as condoms) or use alternative contraceptives (e.g., a combined oral contraceptive containing ethinyl estradiol as the estrogen and levonorgestrel or norethindrone as the progestin, an intrauterine system) during JOURNAVX treatment and for 28 days after discontinuation of JOURNAVX.

'''Risk of Adverse Reactions in Patients with Moderate and Severe Hepatic Impairment'''
Patients with moderate hepatic impairment have higher systemic exposures of suzetrigine and M6-SUZ (active metabolite) than those with normal hepatic function which may increase the risk of JOURNAVX related adverse reactions.Avoid use of JOURNAVX in patients with severe hepatic impairment (Child-Pugh Class C). The recommended JOURNAVX dosage is lower in patients with moderate hepatic impairment (Child-Pugh Class B) than those with normal hepatic function.
|clinicalTrials=The safety profile of JOURNAVX is primarily based on data from the pooled, double-blind, placebo- and active-controlled trials in 874 adult patients with moderate to severe acute pain following full abdominoplasty (Trial 1) and bunionectomy (Trial 2), with supportive safety data from one single arm trial in 256 adult patients with moderate to severe acute pain in a broad range of acute pain conditions (Trial 3).

'''Nausea and Vomiting'''

In Trial 1, the incidence of patients who experienced either nausea or vomiting was 20% in JOURNAVX-treated patients, 33% in HB/APAP-treated patients, and 25% in placebo-treated patients. In Trial 2, the incidence of patients who experienced either nausea or vomiting was 9% in JOURNAVX-treated patients, 16% in HB/APAP-treated patients, and 12% in placebo-treated patients.

'''Laboratory Abnormalities'''

Creatine Phosphokinase Elevations: In Trials 1 and 2, 2.9% of JOURNAVX-treated patients and 1.2% of placebo-treated patients had a creatine phosphokinase (CPK) level > 3 times the upper limit of normal. The incidence of increased blood CPK was 1.1% in JOURNAVX-treated patients and 0.5% in placebo-treated patients. All reports of CPK elevations occurred in the post-surgical setting. There were no associated signs or symptoms, no serious adverse reactions, and no patients required treatment discontinuation or interruption.

Decreased Estimated Glomerular Filtration Rate: In Trials 1 and 2, 2.5% of JOURNAVX-treated patients and 0.9% of placebo-treated patients had a decrease in estimated glomerular filtration rate (eGFR) of ≥ 25% but < 50%. Follow-up eGFR data for these controlled trials was not available after treatment discontinuation. Similar decreases in eGFR also occurred in Trial 3 (the open-label Phase 3 study) and appeared to resolve to baseline by the final safety follow-up visit. There was no control arm for comparison. There were no adverse reactions of eGFR decrease in JOURNAVX-treated patients.

'''Adverse Reactions from the Open-Label Study (Trial 3)'''

* In an open-label study of patients with moderate to severe acute pain following a surgical procedure or nonsurgical condition [NCT05661734], a total of 256 adult patients received at least one dose of JOURNAVX. Patients received 100 mg as a first dose, then 50 mg every 12 hours and continued to receive JOURNAVX for up to 14 days or until their pain resolved. Rescue medication of 650 mg of acetaminophen and 400 mg of ibuprofen together every 6 hours was permitted as needed for pain relief. The patients' perceptions of pain control was captured by patient global assessment (PGA). The mean duration of treatment with JOURNAVX was 9.6 days. The majority of patients were female (68%), and the median age was 43 years (range: 18 to 78).

* In Trial 3, a total of 222 (87%) patients received JOURNAVX for post-surgical pain; orthopedic surgery was the most common (e.g., ligament operation, arthrodesis), followed by plastic surgery (e.g., liposuction, mammoplasty), otorhinolaryngologic surgery (e.g., nasal septal operation, turbinoplasty), and general and urologic surgery (e.g., inguinal hernia repair). Thirty-four (13%) patients received JOURNAVX for non-surgical pain (e.g., arthralgias, limb pain, and sprains/strains).

* The proportion of patients who discontinued study drug prematurely was 2% due to adverse events (arrhythmia [0.4%], nausea [0.4%], somnolence [0.4%], rash [0.4%]) and 1.6% due to lack of efficacy.

* The safety profile of JOURNAVX in Trial 3 was consistent with that observed in Trials 1 and 2.
|drugInteractions=====Effect of Other Drugs on JOURNAVX====
* Food or drink containing grapefruit should be avoided during treatment with JOURNAVX.

Table 3.

====Effect of JOURNAVX on Other Drugs====

'''CYP3A Substrates'''

* If JOURNAVX is used concomitantly with sensitive CYP3A substrates or CYP3A substrates where minimal concentration changes may lead to loss of efficacy, refer to the Prescribing Information for the CYP3A substrates for dosing instructions. Dosage modification of the concomitant CYP3A substrates may be required when initiating or discontinuing JOURNAVX.

'''Hormonal Contraceptives'''

* JOURNAVX-treated patients using hormonal contraceptives containing progestins other than levonorgestrel and norethindrone should use additional nonhormonal contraceptives (such as condoms), or use alternative contraceptives (such as a combined oral contraceptive containing ethinyl estradiol as the estrogen and levonorgestrel or norethindrone as the progestin, or an intrauterine system) during treatment with JOURNAVX and for 28 days after discontinuation of JOURNAVX.
* JOURNAVX did not result in clinically significant changes in the pharmacokinetics of ethinyl estradiol and levonorgestrel when used concomitantly with an oral contraceptive containing ethinyl estradiol and levonorgestrel.
|useInPregnancyFDA='''Risk Summary'''

* There are no available data on the use of JOURNAVX during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.
* In animal reproduction studies in rats, effects on implantation and maintenance of pregnancy occurred at oral suzetrigine doses of ≥ 2.2-times the maximum recommended human dose (MRHD) when administered during early embryonic development or throughout organogenesis.
* In a pre- and postnatal development study, reduced mean gestation length and increased postnatal pup mortality were observed at maternal rat exposures of 1.6-times the MRHD and decreased rat pup body weights were observed during the period of birth to weaning at maternal exposures of 2.2-times the MRHD.
* No malformations were observed when suzetrigine was administered orally to rats and rabbits during the period of organogenesis at doses up to 2.2- and 5.9-times, respectively, the MRHD. The clinical relevance of these findings is unclear.
* The background risk of major birth defects and miscarriage in patients with moderate to severe acute pain is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
* In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
|useInNursing='''Risk Summary'''

* There are no data on the presence of suzetrigine or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production.
* Suzetrigine is present in animal milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk.
* The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for JOURNAVX and any potential adverse effects on the breastfed child from JOURNAVX or from the underlying maternal condition.
|useInPed=The safety and effectiveness of JOURNAVX has not been established in pediatric patients.
|useInGeri=* Of the total 1130 patients with moderate to severe acute pain who received JOURNAVX in the Phase 3 studies, 71 patients (6.3%) were 65 years of age and older.
* Clinical studies of JOURNAVX did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger patients. However, based on population pharmacokinetic analyses in patients with ages ranging from 18 to 75 years, age does not have a clinically relevant impact on suzetrigine exposure.
|useInRenalImpair=* JOURNAVX has not been studied in patients with renal impairment of eGFR < 15 mL/min.
* Avoid use of JOURNAVX in patients with renal impairment of eGFR < 15 mL/min.
* The recommended dosage in patients with eGFR > 15 mL/min is the same as those with normal kidney function.
|useInHepaticImpair=* Avoid use of JOURNAVX in patients with severe hepatic impairment (Child-Pugh Class C.
* The recommended JOURNAVX dosage is lower in patients with moderate hepatic impairment (Child-Pugh Class B) than those with normal hepatic function.
* The recommended dosage in patients with mild hepatic impairment (Child-Pugh Class A) is the same as those with normal hepatic function.
* Patients with moderate hepatic impairment had greater suzetrigine and M6-SUZ (the active metabolite) exposure than those with normal hepatic function, which may increase the risk of suzetrigine adverse reactions.

Add table 1
|useInReproPotential='''Contraception'''

* Advise patients using hormonal contraceptives containing progestins other than levonorgestrel and norethindrone to use an additional nonhormonal contraceptive or to use alternative contraceptives during JOURNAVX treatment and for 28 days after discontinuation of JOURNAVX.

'''Infertility'''
* In a female fertility study in rats, increased pre-implantation loss was observed at oral suzetrigine doses of ≥ 2.2-times the MRHD when administered prior to mating and through Gestation Day 7.
* Following discontinuation of suzetrigine for 4 weeks, the increased pre-implantation loss in rats was not observed.
* The finding in rats may be explained by the effect of suzetrigine on the rat progesterone receptor, which was more sensitive to suzetrigine than the human progesterone receptor based on in vitro studies.
* JOURNAVX may reversibly impact the likelihood of females of reproductive potential to become pregnant while on treatment. Patients using contraceptives should continue to use contraceptives.
|overdose=* No specific antidote is available for overdose with JOURNAVX. Treatment of overdose consists of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.
|mechAction=Suzetrigine is a selective blocker of the NaV1.8 voltage-gated sodium channel, compared to other known voltage-gated sodium channels (NaV1.1 through 1.9). NaV1.8 is expressed in peripheral sensory neurons including dorsal root ganglion neurons, where its role is to transmit pain signals (action potentials). By selectively inhibiting NaV1.8 channels, suzetrigine inhibits transmission of pain signals to the spinal cord and brain. M6-SUZ, a major active metabolite, is a less potent inhibitor of NaV1.8 than suzetrigine by 3.7-fold.
|structure=The active ingredient in JOURNAVX (suzetrigine) tablets is suzetrigine, a sodium channel blocker, which has the following chemical name:

4-[(2R,3S,4S,5R)-3-(3,4-difluoro-2-methoxyphenyl)-4,5-dimethyl-5-(trifluoromethyl)oxolane-2-amido]pyridine-2-carboxamide. Its molecular formula is C21H20F5N3O4.

Add structure image.
|PD='''Cardiac Electrophysiology'''

At 2 times the exposure of the maximum recommended JOURNAVX dose, clinically significant QTc prolongation was not observed.
|nonClinToxic='''Carcinogenesis'''

* Long-term animal studies have not been completed to evaluate the carcinogenic potential of suzetrigine.

'''Mutagenesis'''

* Suzetrigine was not mutagenic in the bacterial reverse mutation assay (Ames test), or clastogenic in the in vitro micronucleus assay with a human TK6 lymphoblastoid cell line, or in the in vivo rat bone marrow micronucleus assay.

'''Impairment of Fertility'''

* In a female fertility study, female rats were treated orally with suzetrigine at 5, 10, and 15 mg/kg/day for a minimum of 14 days prior to mating, throughout mating, and through Gestation Day 7. These doses are approximately 0.57, 1.6, and 2.2-times the steady state MRHD exposure based on AUC. Increased pre-implantation loss was observed at 15 mg/kg (approximately 2.2-times the MRHD based on AUC).
* In a male fertility study, male rats were treated orally with suzetrigine at 200, 600, and 1000 mg/kg/day for a minimum of 28 days prior to mating and through mating. These doses are 3.6, 9.7, and 13.8-times the steady state MRHD exposure based on AUC, respectively. Suzetrigine had no effects on sperm parameters (motility, concentration, or morphology), reproductive performance or uterine parameters (number of implants, viable implants, pre-implantation loss, early resorptions, and post-implantation loss) at any dose.
|clinicalStudies='''Overview of Clinical Studies'''

* The efficacy of JOURNAVX in the treatment of moderate to severe acute pain in adults was established in two randomized, double-blind, placebo and active-controlled trials of acute pain, one following full abdominoplasty (Trial 1) [see Clinical Studies (14.2)] and the other following bunionectomy (Trial 2) [see Clinical Studies (14.3)].
* In each trial, pain intensity was measured using a patient-reported 11-point numeric pain rating scale (NPRS), ranging from 0 to 10, where zero corresponds to no pain and 10 corresponds to the worst pain imaginable.
* Patients were eligible for study participation if they had moderate to severe pain on the verbal categorical rating system (VRS) and a pain score of ≥ 4 on the NPRS, within 4 hours of the abdominoplasty completion (Trial 1) or during the 9-hour period after discontinuation of regional anesthesia following bunionectomy (Trial 2).
* Once eligible, patients were randomized to receive oral JOURNAVX, placebo, or hydrocodone bitartrate/acetaminophen (HB/APAP) for a duration of 48 hours.
* For the JOURNAVX treatment regimen, patients received an initial loading dose of 100 mg JOURNAVX, followed by 50 mg every 12 hours.
* For the HB/APAP-control regimen, patients received 5 mg/325 mg every 6 hours. * For both studies, 400 mg of ibuprofen every 6 hours, as needed for pain relief, was permitted as a rescue medication.

'''Moderate to Severe Acute Pain Following Full Abdominoplasty'''
* Trial 1 [NCT05558410] evaluated the efficacy of JOURNAVX over 48 hours in 1,118 adult patients with moderate to severe acute pain following a full abdominoplasty procedure (JOURNAVX n = 447, placebo n = 223, and hydrocodone bitartrate/acetaminophen (HB/APAP) n = 448).
* The majority of patients were female (98%), and the mean age was 42 years (range: 18 to 69).
* The study population consisted of 70% White participants, 27% Black or African American participants, 1% Asian participants, 0.8% Native Hawaiian or other Pacific Islander participants, 0.5% American Indian or Alaska Native participants, and 0.9% Other or Multiracial participants, among which 34% identified as Hispanic or Latino. The mean pain score at baseline was 7.4 (range: 4 to 10).
* All baseline characteristics, including NPRS, VRS, and BMI were generally balanced across treatment arms.
* In Trial 1, 89% of patients in the JOURNAVX group completed the treatment period (compared to 75% of patients in the placebo group and 85% of patients in the HB/APAP group), and 9% of patients in the JOURNAVX group discontinued due to lack of efficacy (compared to 22% of patients in the placebo group and 13% of patients in the HB/APAP group).
* Efficacy was evaluated by the time-weighted sum of the pain intensity difference from 0 to 48 hours (SPID48) in the JOURNAVX group compared to the placebo group and then to the HB/APAP group. Treatment with JOURNAVX demonstrated statistically significant superior reduction in pain compared to treatment with placebo.
* The median time to meaningful pain relief (defined as a ≥ 2-point reduction in NPRS) was 119 minutes for patients in the JOURNAVX group and 480 minutes for patients in the placebo group. The median time to onset of perceptible pain relief (defined as a ≥ 1-point reduction in NPRS) for patients in the JOURNAVX group was 34 minutes.

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'''Moderate to Severe Acute Pain Following Bunionectomy'''
* Trial 2 [NCT05553366] evaluated the efficacy of JOURNAVX over 48 hours in 1,073 adult patients with moderate to severe acute pain following bunionectomy (JOURNAVX n = 426, placebo n = 216, and HB/APAP n = 431).
* The majority of patients were female (85%), and the mean age was 48 years (range: 18 to 75).
* The study population consisted of 71% White participants, 24% Black or African American participants, 2% Asian participants, 0.2% Native Hawaiian or other Pacific Islander participants, 1% American Indian or Alaska Native participants, and 1% Other or Multiracial participants, and 0.3% with race missing, among which 34% identified as Hispanic or Latino.
* The mean pain score at baseline was 6.8 (range: 4 to 10). All baseline characteristics, including NPRS, VRS, and BMI were generally balanced across treatment arms.
* In Trial 2, 87% of patients in the JOURNAVX group completed the treatment period (compared to 82% of patients in the placebo group and 90% of patients in the HB/APAP group), and 12% of patients in the JOURNAVX group discontinued due to lack of efficacy (compared to 16% of patients in the placebo group and 8% of patients in the HB/APAP group).
* Efficacy was evaluated by the time-weighted sum of the pain intensity difference from 0 to 48 hours (SPID48) in the JOURNAVX group compared to the placebo group and then to the HB/APAP group.
* In an exploratory analysis, the time-weighted sum of the pain intensity difference from 0 to 24 hours (SPID24) reported using the least square mean was 30.6 in the JOURNAVX group and 19.8 in the placebo group.

add table 6 and figure 2

'''Time to Onset of Pain Relief'''

The median time to meaningful pain relief (defined as ≥ 2-point reduction in NPRS) was 240 minutes for patients in the JOURNAVX group and 480 minutes in the placebo group. The median time to onset of perceptible pain relief (defined as a ≥ 1-point reduction in NPRS) for patients in the JOURNAVX group was 60 minutes.
|howSupplied=JOURNAVX (suzetrigine) tablets are supplied as blue, film-coated, oblong tablets containing 50 mg of suzetrigine. Each tablet is debossed with the characters "VX50" on one side and plain on the other, and is packaged as follows:

* 30-count bottle NDC 51167-548-30
* 100-count bottle NDC 51167-548-31
* 100-count Hospital Unit Dose Carton (10 blister cards, each containing 10 tablets) NDC 51167-548-34
|storage=* Store at 68°F to 77°F (20°C to 25°C); excursions permitted to 59°F to 86°F (15°C to 30°C).
|fdaPatientInfo='''Drug Interactions'''

* Ask patients to tell you all the medications they are taking, including any herbal supplements or vitamins.
* Food or drink containing grapefruit should be avoided.
* When used concomitantly with hormonal contraceptives containing a progestin other than levonorgestrel or norethindrone, advise patients to use an additional nonhormonal contraceptive (such as condoms) or use alternative contraceptives during JOURNAVX treatment and for 28 days after discontinuation of JOURNAVX.

'''Females of Reproductive Potential'''
* Advise females of reproductive potential that JOURNAVX may reversibly impact the likelihood to become pregnant while on treatment.
* Patients using contraceptives should continue to use contraceptives.

'''Use in Patients with Hepatic Impairment'''
* Inquire and/or assess whether patients have hepatic impairment.

'''Administration Instructions'''
* Advise patients to take the starting dose of JOURNAVX on an empty stomach at least 1 hour before or 2 hours after food to avoid delay in onset of action.
* Clear liquids may be consumed (such as water, apple juice, vegetable broth, tea, or black coffee) during this time.
* Avoid food or drink containing grapefruit during treatment with JOURNAVX.
* Subsequent doses of JOURNAVX can be taken with or without food.
* Patients should be instructed to swallow JOURNAVX tablets whole (do not chew or crush).
* Inform patients about what to do in the event they miss a dose of JOURNAVX.
|alcohol=Alcohol-Suzetrigene interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
|brandNames=JOURNAVX
|lookAlike=There is limited information regarding Look-Alike Drug Names to JOURNAVX.
}}

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2026-05-04T16:09:28Z

ACEI / ARB

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Ischemic stroke medical therapy

2026-05-03T15:59:28Z

Overview

← Older revision		Revision as of 15:59, 3 May 2026
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	==Overview==		==Overview==
	~~The medical therapy of [[~~ischemic stroke]] is ~~mainly~~ directed to ~~fibrinolysis of clot by r-tPA~~ with in ~~3 to 4~~.5 hours ~~of symptom~~ onset~~. Acute treatment with antiplatelets may have a role if given within~~ 24~~-48~~ hours ~~of stroke onset~~. ~~Long term management with statins,~~ antiplatelets, ~~anticoagulants~~, ~~antihypertensive and antidiabetic agents may help prevent the recurrence.<ref>{{cite journal \|author=Hackam DG~~, Spence JD \|title=Combining multiple approaches for the secondary prevention of vascular events after stroke: a quantitative modeling study \|journal=Stroke \|volume=38 \|issue=6 \|pages=1881–5 \|year=2007 \|pmid=17431209 \|doi=10.1161/STROKEAHA.106.475525}}</ref>		Acute ischemic stroke therapy is primarily directed to rapid reperfusion with intravenous thrombolysis (alteplase or tenecteplase) in eligible patients and endovascular thrombectomy (EVT) in eligible patients with large vessel occlusion (LVO); these treatments should be considered in parallel and should not delay each other.
	~~Acute treatment to control blood pressure, blood glucose~~ and ~~fever may help prevent the complications and have a prognostic significance~~.
			Antiplatelet therapy (usually aspirin) is recommended within 24–48 hours after onset in most patients who are not receiving IV thrombolysis, and is generally delayed until 24 hours after thrombolysis.

			Secondary prevention includes antiplatelets or anticoagulation depending on etiology (eg, atrial fibrillation), lipid-lowering therapy, and risk-factor management.

	==Medical Therapy==		==Medical Therapy==

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2026-05-03T14:43:03Z

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Hibatullah Abdul Aleem

2026-04-29T16:04:52Z

Created page with "__NOTOC__ ==Hibatullah Abdul Aleem== '''Hibatullah Abdul Aleem''' Contact: Email: [mailto:dr.hibatullah8@gmail.com] ==Current Position== ==Professional Background== ==Education== M.B.B.S fron Shadan Institute Of Medical Sciences ==Brief Biography=="

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__NOTOC__
==Hibatullah Abdul Aleem==
'''Hibatullah Abdul Aleem'''
 Contact: 
Email: [mailto:dr.hibatullah8@gmail.com] 

==Current Position==

==Professional Background==

==Education==
M.B.B.S fron Shadan Institute Of Medical Sciences

==Brief Biography==

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2026-04-29T10:11:34Z

Replaced content with "== '''Thoracic Aortic Aneurysm Medical Therapy''' == <references />"

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Thoracic aortic aneurysm medical therapy

2026-04-29T10:10:34Z

Medical Therapy

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2026-04-29T10:02:24Z

Created page with "HEADING"

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[[HEADING]]

Template:HT

2026-04-29T09:46:56Z

Created page with "Hibatullah Abdul Aleem, M.B.B.S[mailto:dr.hibatullah8@gmail.com]"

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[[User:Hibatullah Abdul Aleem|Hibatullah Abdul Aleem, M.B.B.S]][mailto:dr.hibatullah8@gmail.com]

Datopotamab deruxtecan-dlnk

2026-04-28T18:44:41Z

← Older revision		Revision as of 18:44, 28 April 2026
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	* Store vials in a refrigerator at 2ºC to 8ºC (36ºF to 46ºF) in the original carton to protect from light until time of reconstitution. Do not freeze. Do not shake the reconstituted or diluted solution.		* Store vials in a refrigerator at 2ºC to 8ºC (36ºF to 46ºF) in the original carton to protect from light until time of reconstitution. Do not freeze. Do not shake the reconstituted or diluted solution.
			[[File:Datopotamab display panel.jpeg\|400px\|thumb\|right\|Principle Display Panel]]

	* DATROWAY (datopotamab deruxtecan-dlnk) is a hazardous drug. Follow applicable special handling and disposal procedures.		* DATROWAY (datopotamab deruxtecan-dlnk) is a hazardous drug. Follow applicable special handling and disposal procedures.

File:Datopotamab display panel.jpeg

2026-04-28T14:09:42Z

Anum Ijaz uploaded File:Datopotamab display panel.jpeg

New page

Sandbox

2026-04-28T01:40:03Z

← Older revision		Revision as of 01:40, 28 April 2026
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	* [[Statin\|Statins]]: high-intensity statin therapy for atherosclerotic TAA		* [[Statin\|Statins]]: high-intensity statin therapy for atherosclerotic TAA

	== 2022 ACC/AHA Guidelines for the Diagnosis and Management of Aortic Disease <ref name="pmid36334952">{{cite journal \|vauthors=Isselbacher EM, Preventza O, Hamilton Black Iii J, Augoustides JG, Beck AW, Bolen MA, Braverman AC, Bray BE, Brown-Zimmerman MM, Chen EP, Collins TJ, DeAnda A, Fanola CL, Girardi LN, Hicks CW, Hui DS, Jones WS, Kalahasti V, Kim KM, Milewicz DM, Oderich GS, Ogbechie L, Promes SB, Ross EG, Schermerhorn ML, Times SS, Tseng EE, Wang GJ, Woo YJ \|title=2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease: A Report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines \|journal=J Am Coll Cardiol \|volume=80 \|issue=24 \|pages=e223–e393 \|date=December 2022 \|pmid=36334952 \|pmc=9860464 \|doi=10.1016/j.jacc.2022.08.004 \|url=}}</ref> <ref name="url2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease: A Report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines \| JACC">{{cite web \|url=https://www.jacc.org/doi/10.1016/j.jacc.2022.08.004 \|title=2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease: A Report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines \| JACC \|format= \|work= \|accessdate=}}</ref> ==		==2022 ACC/AHA Guidelines for the Diagnosis and Management of Aortic Disease <ref name="pmid36334952">{{cite journal \|vauthors=Isselbacher EM, Preventza O, Hamilton Black Iii J, Augoustides JG, Beck AW, Bolen MA, Braverman AC, Bray BE, Brown-Zimmerman MM, Chen EP, Collins TJ, DeAnda A, Fanola CL, Girardi LN, Hicks CW, Hui DS, Jones WS, Kalahasti V, Kim KM, Milewicz DM, Oderich GS, Ogbechie L, Promes SB, Ross EG, Schermerhorn ML, Times SS, Tseng EE, Wang GJ, Woo YJ \|title=2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease: A Report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines \|journal=J Am Coll Cardiol \|volume=80 \|issue=24 \|pages=e223–e393 \|date=December 2022 \|pmid=36334952 \|pmc=9860464 \|doi=10.1016/j.jacc.2022.08.004 \|url=}}</ref> <ref name="url2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease: A Report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines \| JACC">{{cite web \|url=https://www.jacc.org/doi/10.1016/j.jacc.2022.08.004 \|title=2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease: A Report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines \| JACC \|format= \|work= \|accessdate=}}</ref>==

	=== Multidisciplinary Aortic Team and Shared Decision-Making<ref name="url2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease: A Report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines \| JACC" /> ===		=== Multidisciplinary Aortic Team and Shared Decision-Making<ref name="url2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease: A Report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines \| JACC" /> ===
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	== '''References''' ==		== '''References''' ==
			<references />

Datopotamab deruxtecan-dlnk

2026-04-28T00:58:04Z

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Sandbox

2026-04-28T00:07:58Z

Multidisciplinary Aortic Team and Shared Decision-Making[2]

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Datopotamab deruxtecan-dlnk

2026-04-27T23:52:27Z

Sandbox

2026-04-27T23:15:44Z

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Atrial fibrillation

2026-04-27T21:51:47Z

Rhythm Control

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User:Hasnain Ali

2026-04-27T20:24:40Z

← Older revision		Revision as of 20:24, 27 April 2026
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	I create original content on my areas of interest and refresh older chapters to keep the medical information current.		I create original content on my areas of interest and refresh older chapters to keep the medical information current.

	* Resident ~~Medical Officer with Dept. of Neurology~~, Liaquat University hospital Hyderabad/Jamshoro, Pakistan.		* Resident, Liaquat University hospital Hyderabad/Jamshoro, Pakistan.

	I provide inpatient and outpatient neurological care, managing up to 5 inpatients daily and around 30 clinic and emergency patients per week. Alongside clinical duties, I participated in multidisciplinary academic activities and contributed to research through systematic data collection and documentation.		I provide inpatient and outpatient neurological care, managing up to 5 inpatients daily and around 30 clinic and emergency patients per week. Alongside clinical duties, I participated in multidisciplinary academic activities and contributed to research through systematic data collection and documentation.

Industrial and organizational psychology

2026-04-27T20:07:19Z

Career calling

← Older revision		Revision as of 20:07, 27 April 2026
(4 intermediate revisions by the same user not shown)
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	* [[Empowerment(psychology)\|Empowerment]]		* [[Empowerment(psychology)\|Empowerment]]
	* [[Engagement (psychology)\|Engagement]]		* [[Engagement (psychology)\|Engagement]]
			* [[Career calling]]
	* [[Job satisfaction]]		* [[Job satisfaction]]
	* [[Burnout (psychology)\|Burnout]]		* [[Burnout (psychology)\|Burnout]]
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	* "Would you say you are thriving or struggling with the following types of bonds or relationships at work?"		* "Would you say you are thriving or struggling with the following types of bonds or relationships at work?"

	A separate body of research has emerged more recently that gives a broader definition to thriving, but does not cite the above research that has used factor analysis to identify core features~~<ref>~~<ref name="pmid28913621">{{cite journal\| author=Brady KJS, Trockel MT, Khan CT, Raj KS, Murphy ML, Bohman B et al.\| title=What Do We Mean by Physician Wellness? A Systematic Review of Its Definition and Measurement. \| journal=Acad Psychiatry \| = 2017 \| volume= \| issue= \| pages= \| pmid=28913621 \| doi=10.1007/s40596-017-0781-6 \| pmc= \| url=https://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=28913621 }} </ref><ref>Feeney, B. C., & Collins, N. L. (2015). A new look at social support: A theoretical perspective on thriving through relationships. Personality and Social Psychology Review, 19(2), 113-147. {{doi\|10.1177/1088868314544222}}</ref>.		A separate body of research has emerged more recently that gives a broader definition to thriving, but does not cite the above research that has used factor analysis to identify core features<ref name="pmid28913621">{{cite journal\| author=Brady KJS, Trockel MT, Khan CT, Raj KS, Murphy ML, Bohman B et al.\| title=What Do We Mean by Physician Wellness? A Systematic Review of Its Definition and Measurement. \| journal=Acad Psychiatry \| = 2017 \| volume= \| issue= \| pages= \| pmid=28913621 \| doi=10.1007/s40596-017-0781-6 \| pmc= \| url=https://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=28913621 }} </ref><ref>Feeney, B. C., & Collins, N. L. (2015). A new look at social support: A theoretical perspective on thriving through relationships. Personality and Social Psychology Review, 19(2), 113-147. {{doi\|10.1177/1088868314544222}}</ref>.

	==== Importance====		==== Importance====
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	* Emotional: I feel energetic at my job; I am enthusiastic in my job		* Emotional: I feel energetic at my job; I am enthusiastic in my job
	* Cognitive: At work, I focus a great deal of attention on my job; At work, I am absorbed by my job		* Cognitive: At work, I focus a great deal of attention on my job; At work, I am absorbed by my job

			===Career calling ===
			Career calling has various definitions, a more recent definition by Rosso and Wrzesniewski is, "meaningful beckoning toward work activities that are morally, socially, and personally significant"<ref name="Rosso2010">{{cite journal \| last1=Rosso \| first1=Brent D. \| last2=Dekas \| first2=Kathryn H. \| last3=Wrzesniewski \| first3=Amy \| title=On the meaning of work: A theoretical integration and review \| journal=Research in Organizational Behavior \| volume=30 \| date=2010 \| doi=10.1016/j.riob.2010.09.001 \| pages=91–127 \| url=https://linkinghub.elsevier.com/retrieve/pii/S0191308510000067 \| access-date=2026-04-27}}</ref>. calling can be measured with<ref name="Dik2012">{{cite journal \| last1=Dik \| first1=Bryan J. \| last2=Eldridge \| first2=Brandy M. \| last3=Steger \| first3=Michael F. \| last4=Duffy \| first4=Ryan D. \| title=Development and Validation of the Calling and Vocation Questionnaire (CVQ) and Brief Calling Scale (BCS) \| journal=Journal of Career Assessment \| volume=20 \| issue=3 \| date=2012 \| issn=1069-0727 \| doi=10.1177/1069072711434410 \| pages=242–263 \| url=https://journals.sagepub.com/doi/10.1177/1069072711434410 \| access-date=2026-04-27}}</ref>:
			# I have a calling to my current line of work.
			# I have a good understanding of my calling as it applies to my career.

			Career calling can be promoted by a career calling climate at work<ref name="Chen 2025">{{cite journal \| last1=Chen \| first1=Jiatian \| last2=May \| first2=Douglas R. \| last3=Schwoerer \| first3=Catherine E. \| title=Career calling climate: The development and validation of a scale for a new construct \| journal=Journal of Management & Organization \| volume=31 \| issue=4 \| date=2025 \| issn=1833-3672 \| doi=10.1017/jmo.2023.16 \| pages=1688–1707 \| url=https://www.cambridge.org/core/product/identifier/S1833367223000160/type/journal_article \| access-date=2026-04-27}}</ref>.

			Calling may increase engagement at work, especially is organizational commitment is present<ref name="Cao2019">{{cite journal \| last1=Cao \| first1=Yudi \| last2=Liu \| first2=Jingying \| last3=Liu \| first3=Kejia \| last4=Yang \| first4=Mengyu \| last5=Liu \| first5=Yanhui \| title=The mediating role of organizational commitment between calling and work engagement of nurses: A cross-sectional study \| journal=International Journal of Nursing Sciences \| volume=6 \| issue=3 \| date=2019-07-10 \| issn=2352-0132 \| pmid=31508452 \| pmc=6722477 \| doi=10.1016/j.ijnss.2019.05.004 \| pages=309–314 \| url=https://pubmed.ncbi.nlm.nih.gov/31508452 \| access-date=2026-04-27}}</ref> as measured by the organizational commitment scale (OCS)<ref name="Allen2011">{{cite journal \| last1=Allen \| first1=Natalie J. \| last2=Meyer \| first2=John P. \| title=The measurement and antecedents of affective, continuance and normative commitment to the organization \| journal=Journal of Occupational Psychology \| volume=63 \| issue=1 \| date=1990 \| issn=0305-8107 \| doi=10.1111/j.2044-8325.1990.tb00506.x \| pages=1–18 \| url=https://bpspsychub.onlinelibrary.wiley.com/doi/10.1111/j.2044-8325.1990.tb00506.x \| access-date=2026-04-27}}</ref>.

	===Satisfaction===		===Satisfaction===

Atrial fibrillation overview

2026-04-27T17:15:33Z

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Supraventricular tachycardia

2026-04-27T17:08:57Z

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Chronic stable angina overview

2026-04-25T15:44:25Z

Treatment

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← Older revision		Revision as of 23:52, 27 April 2026
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	DATROWAY can cause severe, life-threatening, or fatal interstitial lung disease (ILD) or pneumonitis.		DATROWAY can cause severe, life-threatening, or fatal interstitial lung disease (ILD) or pneumonitis.

	Locally Advanced or Metastatic NSCLC		'''Locally Advanced or Metastatic NSCLC''

	In the pooled safety population of 484 patients with NSCLC from TROPION-Lung01, TROPION-Lung05, and TROPION-PanTumor01 ~~[see Adverse Reactions (6.1)]~~, ILD/pneumonitis occurred in 7% of patients treated with DATROWAY, including 0.6% of patients with Grade 3 and 0.4% with Grade 4. There were 8 (1.7%) fatal cases. The median time to onset for ILD was 1.4 months (range: 0.2 months to 9 months). Eleven patients (2.3%) had DATROWAY withheld and 20 patients (4.1%) permanently discontinued DATROWAY due to ILD/pneumonitis. Systemic corticosteroids were required in 79% (26/33) of patients with ILD/pneumonitis. ILD/pneumonitis resolved in 45% of patients.		In the pooled safety population of 484 patients with NSCLC from TROPION-Lung01, TROPION-Lung05, and TROPION-PanTumor01, ILD/pneumonitis occurred in 7% of patients treated with DATROWAY, including 0.6% of patients with Grade 3 and 0.4% with Grade 4. There were 8 (1.7%) fatal cases. The median time to onset for ILD was 1.4 months (range: 0.2 months to 9 months). Eleven patients (2.3%) had DATROWAY withheld and 20 patients (4.1%) permanently discontinued DATROWAY due to ILD/pneumonitis. Systemic corticosteroids were required in 79% (26/33) of patients with ILD/pneumonitis. ILD/pneumonitis resolved in 45% of patients.

	Unresectable or Metastatic Breast Cancer		Unresectable or Metastatic Breast Cancer
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	The safety of DATROWAY was evaluated in 125 patients with EGFR-mutated NSCLC who received DATROWAY 6 mg/kg administered as an intravenous infusion once every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity in TROPION-Lung05 and TROPION-Lung01 ~~[see Clinical Studies (14.1)]~~ as well as TROPION-PanTumor01 (NCT03401385). Among these patients, the median duration of treatment was 6.1 months (range 0.7 months to 41.7 months).		The safety of DATROWAY was evaluated in 125 patients with EGFR-mutated NSCLC who received DATROWAY 6 mg/kg administered as an intravenous infusion once every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity in TROPION-Lung05 and TROPION-Lung01 as well as TROPION-PanTumor01 (NCT03401385). Among these patients, the median duration of treatment was 6.1 months (range 0.7 months to 41.7 months).

	The median age was 63 years (range: 36 to 81), 56% of patients were <65 years, 62% of patients were female; 66% were Asian, 26% were White, 0.8% were Black, 6% were other races; and 2.4% were of Hispanic ethnicity.		The median age was 63 years (range: 36 to 81), 56% of patients were <65 years, 62% of patients were female; 66% were Asian, 26% were White, 0.8% were Black, 6% were other races; and 2.4% were of Hispanic ethnicity.
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	Reconstitute immediately before dilution.		Reconstitute immediately before dilution.
	More than one vial may be needed for a full dose. Calculate the dose (mg), the total volume of reconstituted DATROWAY solution required, and the number of vial(s) of DATROWAY needed ~~[see Dosage and Administration (2.2)]~~.		More than one vial may be needed for a full dose. Calculate the dose (mg), the total volume of reconstituted DATROWAY solution required, and the number of vial(s) of DATROWAY needed.
	Reconstitute each 100 mg vial using a sterile syringe to slowly inject 5 mL of Sterile Water for Injection into each vial to obtain a final concentration of 20 mg/mL.		Reconstitute each 100 mg vial using a sterile syringe to slowly inject 5 mL of Sterile Water for Injection into each vial to obtain a final concentration of 20 mg/mL.
	Swirl the vial gently until completely dissolved. Do not shake.		Swirl the vial gently until completely dissolved. Do not shake.
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	Interstitial Lung Disease/Pneumonitis		Interstitial Lung Disease/Pneumonitis

	Inform patients of the risks of severe or fatal ILD. Advise patients to contact their healthcare provider immediately for any of the following: cough, shortness of breath, fever, or other new or worsening respiratory symptoms ~~[see Warnings and Precautions (5.1)]~~.		Inform patients of the risks of severe or fatal ILD. Advise patients to contact their healthcare provider immediately for any of the following: cough, shortness of breath, fever, or other new or worsening respiratory symptoms.
	Ocular Adverse Reactions		Ocular Adverse Reactions

	Inform patients about the need for eye exams at initiation and during treatment with DATROWAY ~~[see Dosage and Administration (2.3)]~~.		Inform patients about the need for eye exams at initiation and during treatment with DATROWAY .
	Advise patients to contact their healthcare provider if they experience any eye symptoms.		Advise patients to contact their healthcare provider if they experience any eye symptoms.
	Advise patients to use preservative-free lubricating eye drops several times daily and to avoid use of contact lenses during treatment with DATROWAY.		Advise patients to use preservative-free lubricating eye drops several times daily and to avoid use of contact lenses during treatment with DATROWAY.