Iptacopa

Iptacopa
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rithish Nimmagadda,MBBS.[2]

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Black Box Warning

Serious Infections Caused By Encapsulated Bacteria See full prescribing information for complete Boxed Warning. Iptacopan hydrochloride increases the risk of serious and life-threatening infections caused by encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B. Complete or update vaccination for encapsulated bacteria at least 2 weeks prior to the first dose of iptacopan, unless the risks of delaying therapy outweigh the risk of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against encapsulated bacteria in patients receiving a complement inhibitor. Patients receiving iptacopan are at increased risk for invasive disease caused by encapsulated bacteria, even if they develop antibodies following vaccination. [ref] Monitor patients for early signs and symptoms of serious infections and evaluate immediately if infection is suspected. Iptacopan is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called Fabhalta REMS.

Overview

Iptacopa is a complement factor B inhibitor. that is FDA approved for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH).. There is a Black Box Warning for this drug as shown here. Common adverse reactions include Most common adverse reactions in adults with PNH (incidence ≥10%) were headache, nasopharyngitis, diarrhea, abdominal pain, bacterial infection, viral infection, nausea, and rash..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Capsules: 200 mg (of iptacopan)

Off-Label Use and Dosage (Adult)

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Iptacopa FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Contraindications

Serious hypersensitivity to iptacopan or any of the excipients.

Initiation in patients with unresolved serious infection caused by encapsulated bacteria.

Warnings

Serious Infections Caused By Encapsulated Bacteria See full prescribing information for complete Boxed Warning. Iptacopan hydrochloride increases the risk of serious and life-threatening infections caused by encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B. Complete or update vaccination for encapsulated bacteria at least 2 weeks prior to the first dose of iptacopan, unless the risks of delaying therapy outweigh the risk of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against encapsulated bacteria in patients receiving a complement inhibitor. Patients receiving iptacopan are at increased risk for invasive disease caused by encapsulated bacteria, even if they develop antibodies following vaccination. [ref] Monitor patients for early signs and symptoms of serious infections and evaluate immediately if infection is suspected. Iptacopan is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called Fabhalta REMS.

Serious Infections Caused by Encapsulated Bacteria

Iptacopan hydrochloride, a complement inhibitor, increases a patient’s susceptibility to serious, life-threatening, or fatal infections caused by encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis (caused by any serogroup, including non-groupable strains), and Haemophilus influenzae Type B. . Life-threatening and fatal infections with encapsulated bacteriahave occurred in both vaccinated and unvaccinated patients treated with complement inhibitors. . The initiation of iptacopan treatment is contraindicated in patients with unresolved serious infections caused by encapsulated bacteria. . Complete or update vaccination against encapsulated bacteria at least 2 weeks prior to administration of the first dose of iptacopan, according to the current ACIP recommendations for patients receiving a complement inhibitor. . Revaccinate patients in accordance with ACIP recommendations considering the duration of therapy with iptacopan. . Note that ACIP recommends an administration schedule in patients receiving complement inhibitors that differs from the administration schedule in the vaccine prescribing information. . If urgent iptacopan therapy is indicated in a patient who is not up to date with vaccines against encapsulated bacteria according to ACIP recommendations, provide the patient with antibacterial drug prophylaxis and administer these vaccines as soon as possible. . Various durations and regimens of antibacterial drug prophylaxis have been considered, but the optimal durations and drug regimens for prophylaxis and their efficacy have not been studied in unvaccinated or vaccinated patients receiving complement inhibitors, including iptacopan. . The benefits and risks of treatment with iptacopan, as well as the benefits and risks of antibacterial drug prophylaxis in unvaccinated or vaccinated patients, must be considered against the known risks for serious infections caused by encapsulated bacteria. . Vaccination does not eliminate the risk of serious encapsulated bacterial infections, despite development of antibodies following vaccination. . Closely monitor patients for early signs and symptoms of serious infection and evaluate patients immediately if an infection is suspected. . Inform patients of these signs and symptoms and instruct patients to seek immediate medical care if these signs and symptoms occur. . Promptly treat known infections. . Serious infection may become rapidly life-threatening or fatal if not recognized and treated early. . Consider interruption of iptacopan in patients who are undergoing treatment for serious infections. . REMS Iptacopan is available only through a restricted program under a REMS called Fabhalta REMS, because of the risk of serious infections caused by encapsulated bacteria. . Notable requirements of the REMS program include the following: . Prescribers must enroll in the REMS. . Prescribers must counsel patients about the risk of serious infections caused by encapsulated bacteria. . Prescribers must provide patients with the REMS educational materials. . Prescribers must assess patient vaccination status for vaccines against encapsulated bacteria and vaccinate if needed according to current ACIP recommendations 2 weeks prior to the first dose of iptacopan. . Prescribers must provide a prescription for antibacterial drug prophylaxis if treatment must be started urgently, and the patient is not up to date with vaccines against encapsulated bacteria according to current ACIP recommendations at least 2 weeks prior to the first dose of iptacopan. . Pharmacies that dispense iptacopan must be certified in the REMS program and must verify prescribers are certified. . Patients must receive counseling from the prescriber about the need to receive vaccinations against encapsulated bacteria per ACIP recommendations, the need to take antibiotics as directed by the prescriber, and the early signs and symptoms of serious infections. . Patients must be instructed to carry the Patient Safety Card with them at all times during treatment and for 2 weeks following the last dose of iptacopan. . Further information is available by telephone: 1-833-99FABHA or online at www.FABHALTA-REMS.com. . Monitoring of PNH Manifestations after Iptacopan Discontinuation After discontinuing treatment with iptacopan, closely monitor patients for at least 2 weeks after the last dose for signs and symptoms of hemolysis. . These signs include elevated lactate dehydrogenase (LDH) levels along with a sudden decrease in hemoglobin or PNH clone size, fatigue, hemoglobinuria, abdominal pain, dyspnea, major adverse vascular events (such as thrombosis, stroke and myocardial infarction), dysphagia, or erectile dysfunction. . If discontinuation of iptacopan is necessary, consider alternative therapy. . If hemolysis occurs after discontinuation of iptacopan, consider restarting treatment with the drug, if appropriate, or initiating another treatment for PNH. . Hyperlipidemia Iptacopan increases total cholesterol, LDL-cholesterol, and serum triglycerides. . Of the 54 iptacopan-treated patients who had a normal total cholesterol level at baseline in the APPLY-PNH study, 43% developed Grade 1 hypercholesterolemia during the randomized treatment period. . One iptacopan-treated patient in APPLY-PNH experienced increased total cholesterol that worsened to Grade 2 from Grade 1 at baseline. . Of the 34 iptacopan-treated patients who had a normal cholesterol level at baseline in the APPOINT-PNH study, 24% developed Grade 1 hypercholesterolemia during the core treatment period. . Of the 60 iptacopan-treated patients who had LDL-cholesterol ≤130 mg/dL at baseline in APPLY-PNH, 17% developed LDL-cholesterol >130-160 mg/dL, 8% developed LDL-cholesterol >160-190 mg/dL, and 7% developed LDL-cholesterol >190 mg/dL during the randomized treatment period. . Of the 36 iptacopan-treated patients who had LDL-cholesterol ≤130 mg/dL at baseline in APPOINT-PNH, 11% developed LDL-cholesterol >130-160 mg/dL and 3% developed LDL-cholesterol >160-190 mg/dL. . Of the 52 patients with normal triglyceride levels at baseline in APPLY-PNH, 23% developed Grade 1 elevated triglyceridesduring the randomized treatment period. . Three iptacopan-treated patients in APPLY-PNH experienced an increase in triglycerides from Grade 1 to Grade 2. . Of the 37 iptacopan-treated patients who had a normal triglyceride level at baseline in APPOINT-PNH, 27% developed Grade 1 elevated triglycerides in the core treatment period. . Some patients required cholesterol-lowering medications. . Monitor serum lipid parameters periodically during treatment with iptacopan and initiate cholesterol-lowering medication, if indicated.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Iptacopa Clinical Trials Experience in the drug label.

Postmarketing Experience

Most common adverse reactions in adults with PNH (incidence ≥10%) were headache, nasopharyngitis, diarrhea, abdominal pain, bacterial infection, viral infection, nausea, and rash.

Drug Interactions

It isessential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:

CYP2C8 inducers (e.g., rifampin): May decrease iptacopan exposure. Monitor for loss of efficacy.

Strong CYP2C8 inhibitors (e.g., gemfibrozil): May increase iptacopan exposure. Coadministration not recommended.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Iptacopa in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Iptacopa in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Iptacopa during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Iptacopa in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Iptacopa in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Iptacopa in geriatric settings.

Gender

There is no FDA guidance on the use of Iptacopa with respect to specific gender populations.

Race

There is no FDA guidance on the use of Iptacopa with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Iptacopa in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Iptacopa in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Iptacopa in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Iptacopa in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Iptacopa Administration in the drug label.

Monitoring

There is limited information regarding Iptacopa Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Iptacopa and IV administrations.

Overdosage

There is limited information regarding Iptacopa overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Iptacopa Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Iptacopa Mechanism of Action in the drug label.

Structure

There is limited information regarding Iptacopa Structure in the drug label.

Pharmacodynamics

There is limited information regarding Iptacopa Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Iptacopa Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Iptacopa Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Iptacopa Clinical Studies in the drug label.

How Supplied

There is limited information regarding Iptacopa How Supplied in the drug label.

Storage

There is limited information regarding Iptacopa Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

Advise patients to read the FDA-approved patient labeling (Medication Guide). . •Advise patients of the risk of serious infection. . Inform patients of the need to complete or update their vaccinations against encapsulated bacteria at least 2 weeks prior to receiving the first dose of iptacopan or receive antibacterial drug prophylaxis if treatment must be initiated immediately and they have not been previously vaccinated. . Inform patients of the requirement to be revaccinated according to current ACIP recommendations for encapsulated bacteria while on iptacopan therapy.

•Inform patients that vaccination may not prevent serious infection and to seek immediate medical attention if the following signs or symptoms occur: fever with or without shivers or chills; fever and a rash; fever with chest pain and cough; fever with breathlessness/fast breathing; fever with high heart rate; headache with nausea or vomiting; headache and a fever; headache with a stiff neck or stiff back; confusion; body aches with flu-like symptoms; clammy skin; eyes sensitive to light.

•Inform patients that they will be given a Patient Safety Card for iptacopan that they should carry with them at all times during and for 2 weeks following treatment with the drug. . This card describes symptoms which, if experienced, should prompt the patient to seek immediate medical evaluation.

•Iptacopan is available only through a restricted program called Fabhalta REMS. . Patients must receive counseling about the risk of serious infections caused by encapsulated bacteria. . Patients must receive written educational materials about this risk. . •Inform patients with PNH of the importance of taking iptacopan as prescribed in order to minimize the risk of hemolysis.

•Inform patients with PNH that they may develop serious hemolysis due to PNH if iptacopan is discontinued and that they should be monitored by their healthcare providers for at least 2 weeks following discontinuation of the drug.

•Inform patients that iptacopan may increase their cholesterol and triglycerides and that monitoring of these parameters will be needed periodically during treatment.

Precautions with Alcohol

Alcohol-Iptacopa interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.

Brand Names

Fabhalta®

Look-Alike Drug Names

There is limited information regarding Iptacopa Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.