Rifapentine adverse reactions: Difference between revisions

Jump to navigation Jump to search
(Created page with "__NOTOC__ {{Rifapentine }} {{CMG}}; {{AE}} {{chetan}} <ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = PRIFTIN (RIFAPENTINE) TABLET, FILM CO...")
 
No edit summary
Line 3: Line 3:
{{CMG}}; {{AE}} {{chetan}}
{{CMG}}; {{AE}} {{chetan}}


==Adverse Reactions==
Treatment-emergent adverse reactions reported during treatment and post-treatment through the first three months of follow-up in <1% of the rifapentine combination therapy patients are presented below by body system in order of frequency.


===Renal & Urinary===
Urethral disorder, dysuria, [[pyelonephritis]], [[urinary incontinence]], urination disorder.


===Metabolic & Nutritional===
Weight decrease, BUN increased, diabetes mellitus, alkaline phosphatase increased, [[hypophosphatemia]], [[hypercalcemia]], [[hypovolemia]], weight increase.


===Hematologic===
[[Lymphocytosis]], [[hematoma]], [[purpura]], anemia hypochromic, anemia normocytic, thrombosis.


===Body as a Whole - General===
Laboratory test abnormal, edema legs, asthenia, edema face, abscess, edema peripheral, malaise.


===Dermatologic===
Skin ulceraction, urticaria, dry skin, [[furunculosis]], skin discoloration, dermatitis fungal, nail disorder, alopecia, rash erythematous.


===Respiratory===
Abnormal breath sounds, pneumothorax, pneumonia, pleural effusion, rhinitis, dyspnea, [[pneumonitis]], sinusitis, sputum increased, pulmonary fibrosis, upper respiratory congestion, asthma, chest x-ray abnormal, bronchospasm, laryngeal edema, laryngitis, respiratory disorder.


<ref name="dailymed.nlm.nih.gov">{{Cite web  | last =  | first =  | title = PRIFTIN (RIFAPENTINE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=f768e337-a948-420a-9fbe-9be359c7a170 | publisher =  | date =  | accessdate = }}</ref>
===Gastrointestinal===
Tooth disorder, [[gastroenteritis]], [[gastritis]], [[esophagitis]], [[cheilitis]], dry mouth, [[pancreatitis]], [[proctitis]], salivary gland enlargement, tenesmus, gastrointestinal disorder not specified.
 
===Infectious Disease===
Infection fungal, infection parasitic, infection protozoan.
 
===Hepatic & Biliary===
Bilirubinemia, [[hepatomegaly]], jaundice.
 
===Neurologic===
Somnolence, seizure not specified, [[dysphonia]], [[hypoesthesia]], torticollis, hypertonia, hyporeflexia, [[meningitis]], migraine headache, stupor.
 
===Psychiatric===
Anxiety, confusion, drug abuse, aggressive reaction, agitation.
 
===Musculoskeletal===
[[Myalgia]], [[myositis]], bone fracture, muscle weakness, muscle spasm.
 
===Cardiovascular===
Syncope, tachycardia, palpitation, [[hypotension orthostatic]], [[pericarditis]].
 
===Reproductive Disorders===
Penis disorder, [[vaginitis]], vaginal hemorrhage, cervical smear test positive, [[leukorrhea]], mastitis male, prostatic disorder.
 
===Hearing & Vestibular===
Ear disorder not specified, otitis media, earache, otitis externa, tympanic membrane perforation.
 
===Ophthalmologic===
Eye pain, eye abnormality.
 
===Neoplasms===
Pulmonary carcinoma, neoplasm not specified, carcinoma, [[lipoma]].
 
===Vascular (Extracardiac)===
Thrombophlebitis deep, vascular disorder, vasodilation.
 
===Special Senses Other===
Taste loss.
 
===Pregnancy, puerperium and perinatal conditions===
Abortion
 
In another randomized, open-label trial in 1075 HIV seronegative and seropositive patients with pulmonary tuberculosis the overall adverse event rate did not differ substantially from the previous trial. Patients who had completed an initial 2 month phase of treatment with 4 drugs were randomly assigned to receive either rifapentine 600 mg and isoniazid once weekly or rifampin and isoniazid twice weekly for the 4 month continuation phase.
 
In the rifapentine arm, 502 HIV seronegative and 36 HIV seropositive patients were randomized and in the rifampin arm 502 HIV seronegative and 35 HIV seropositive patients were randomized to treatment.
 
The death rate among all study participants was 71/1075 (6.6%) and did not differ between the two treatment groups (6.5% for the rifapentine combination regimen compared to 6.7% for the rifampin combination regimen; P = 0.87).
 
There were 526 treatment-emergent adverse events regardless of causality reported from 251 patients treated with the rifapentine combination regimen and 513 adverse events reported from 248 patients treated with the rifampin combination regimen. On both study arms the most frequently reported adverse events were [[hyperglycemia]], [[pneumonia]], [[liver toxicity]], and death and were consistent with concurrent underlying conditions that included alcohol abuse, [[pancreatitis]] and HIV.
 
There was a greater percentage of patients in the rifampin combination arm who developed hepatic adverse events (35/513; 6.8 %) compared to 20/526 (3.8%) in the rifapentine combination arm. The types of other adverse events were similar between the treatment arms.
 
Hyperuricemia was not reported as an adverse reaction in this study of continuation phase therapy. In the previous study which evaluated initial therapy containing [[pyrazinamide]], [[hyperuricemia]] was reported in 32% of rifapentine and 23% of rifampin combination treated patients (see Table 1). <ref name="dailymed.nlm.nih.gov">{{Cite web  | last =  | first =  | title = PRIFTIN (RIFAPENTINE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=f768e337-a948-420a-9fbe-9be359c7a170 | publisher =  | date =  | accessdate = }}</ref>





Revision as of 03:55, 6 January 2014

Rifapentine
FDA Package Insert (PRIFTIN®)
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Overdosage
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]

Adverse Reactions

Treatment-emergent adverse reactions reported during treatment and post-treatment through the first three months of follow-up in <1% of the rifapentine combination therapy patients are presented below by body system in order of frequency.

Renal & Urinary

Urethral disorder, dysuria, pyelonephritis, urinary incontinence, urination disorder.

Metabolic & Nutritional

Weight decrease, BUN increased, diabetes mellitus, alkaline phosphatase increased, hypophosphatemia, hypercalcemia, hypovolemia, weight increase.

Hematologic

Lymphocytosis, hematoma, purpura, anemia hypochromic, anemia normocytic, thrombosis.

Body as a Whole - General

Laboratory test abnormal, edema legs, asthenia, edema face, abscess, edema peripheral, malaise.

Dermatologic

Skin ulceraction, urticaria, dry skin, furunculosis, skin discoloration, dermatitis fungal, nail disorder, alopecia, rash erythematous.

Respiratory

Abnormal breath sounds, pneumothorax, pneumonia, pleural effusion, rhinitis, dyspnea, pneumonitis, sinusitis, sputum increased, pulmonary fibrosis, upper respiratory congestion, asthma, chest x-ray abnormal, bronchospasm, laryngeal edema, laryngitis, respiratory disorder.

Gastrointestinal

Tooth disorder, gastroenteritis, gastritis, esophagitis, cheilitis, dry mouth, pancreatitis, proctitis, salivary gland enlargement, tenesmus, gastrointestinal disorder not specified.

Infectious Disease

Infection fungal, infection parasitic, infection protozoan.

Hepatic & Biliary

Bilirubinemia, hepatomegaly, jaundice.

Neurologic

Somnolence, seizure not specified, dysphonia, hypoesthesia, torticollis, hypertonia, hyporeflexia, meningitis, migraine headache, stupor.

Psychiatric

Anxiety, confusion, drug abuse, aggressive reaction, agitation.

Musculoskeletal

Myalgia, myositis, bone fracture, muscle weakness, muscle spasm.

Cardiovascular

Syncope, tachycardia, palpitation, hypotension orthostatic, pericarditis.

Reproductive Disorders

Penis disorder, vaginitis, vaginal hemorrhage, cervical smear test positive, leukorrhea, mastitis male, prostatic disorder.

Hearing & Vestibular

Ear disorder not specified, otitis media, earache, otitis externa, tympanic membrane perforation.

Ophthalmologic

Eye pain, eye abnormality.

Neoplasms

Pulmonary carcinoma, neoplasm not specified, carcinoma, lipoma.

Vascular (Extracardiac)

Thrombophlebitis deep, vascular disorder, vasodilation.

Special Senses Other

Taste loss.

Pregnancy, puerperium and perinatal conditions

Abortion

In another randomized, open-label trial in 1075 HIV seronegative and seropositive patients with pulmonary tuberculosis the overall adverse event rate did not differ substantially from the previous trial. Patients who had completed an initial 2 month phase of treatment with 4 drugs were randomly assigned to receive either rifapentine 600 mg and isoniazid once weekly or rifampin and isoniazid twice weekly for the 4 month continuation phase.

In the rifapentine arm, 502 HIV seronegative and 36 HIV seropositive patients were randomized and in the rifampin arm 502 HIV seronegative and 35 HIV seropositive patients were randomized to treatment.

The death rate among all study participants was 71/1075 (6.6%) and did not differ between the two treatment groups (6.5% for the rifapentine combination regimen compared to 6.7% for the rifampin combination regimen; P = 0.87).

There were 526 treatment-emergent adverse events regardless of causality reported from 251 patients treated with the rifapentine combination regimen and 513 adverse events reported from 248 patients treated with the rifampin combination regimen. On both study arms the most frequently reported adverse events were hyperglycemia, pneumonia, liver toxicity, and death and were consistent with concurrent underlying conditions that included alcohol abuse, pancreatitis and HIV.

There was a greater percentage of patients in the rifampin combination arm who developed hepatic adverse events (35/513; 6.8 %) compared to 20/526 (3.8%) in the rifapentine combination arm. The types of other adverse events were similar between the treatment arms.

Hyperuricemia was not reported as an adverse reaction in this study of continuation phase therapy. In the previous study which evaluated initial therapy containing pyrazinamide, hyperuricemia was reported in 32% of rifapentine and 23% of rifampin combination treated patients (see Table 1). [1]


References

  1. "PRIFTIN (RIFAPENTINE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]".

Adapted from the FDA Package Insert.