Priftin Side Effects

Generic Name: rifapentine

Please note - some side effects for Priftin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Priftin - for the Consumer

Priftin

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Priftin:

Acne; discoloration of body fluids; dizziness; headache; pain; stomach pain; upset stomach.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); appetite loss; dark urine; diarrhea; fever; general body discomfort; joint pain or swelling; nausea; pale stools; sore throat; unusual fatigue; vomiting; yellowing of the skin or eyes.

Priftin Side Effects - for the Professional

Priftin

The most common adverse reactions (≥10%) are hyperuricemia, pyuria, hematuria, urinary tract infection, proteinuria, lymphopenia, neutropenia, anemia, and hypoglycemia. (6.2)

To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis U.S. LLC at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Side Effects by Body System

General

In general, there are no data concerning the adverse effects of rifapentine in monotherapy. The following adverse effects have been reported during treatment in the intensive phase (i.e., rifapentine 2 times a week and isoniazid, pyrazinamide and ethambutol daily for 2 months) and the continuation phase (i.e., rifapentine and isoniazid once a week for 4 months) in a clinical study in which 361 patients were randomized to the rifapentine regimen.

Hematologic

Hematologic side effects have included neutropenia (12.5%), lymphopenia (12.7%), anemia (12.2%), leukopenia (6.6%), thrombocytosis (5.5%), leukocytosis (3%), neutrophilia (2.5%), thrombocytopenia (2.5%), polycythemia (2.2%), and lymphadenopathy (1.1%). Lymphocytosis, hematoma, purpura, hypochromic anemia, normocytic anemia, and thrombosis have been reported in less than 1% of patients.

Metabolic

Metabolic side effects have included hyperuricemia (31.9), hypoglycemia (10%), hyperkalemia (9.1%), increased nonprotein nitrogen (3.9%), hyperglycemia (3.6%), increased lactate dehydrogenase (1.4%), and hyperphosphatemia (1.4%). Weight decrease, diabetes mellitus, increased alkaline phosphatase, hypophosphatemia, hypercalcemia, hypovolemia, and weight increase have been reported in less than 1% of patients.

Hyperuricemia was most likely related to pyrazinamide as only 2 cases were reported during the continuation phase, when pyrazinamide was no longer part of the regimen.

Genitourinary

Genitourinary side effects have included proteinuria (13%), pyuria (21.6%), urinary tract infection (13.3%), urinary casts (8%), cystitis (1.7%), and hematuria (17.7%). Urethral disorder, dysuria, pyelonephritis, urinary incontinence, urination disorder, penis disorder, vaginitis, vaginal hemorrhage, positive cervical smear test, leukorrhea, male mastitis, prostatic disorder, and abortion have been reported in less than 1% of patients.

Respiratory

Respiratory side effects have included hemoptysis (8.3%), coughing (8%), upper respiratory tract infection (4.7%), bronchitis (2.5%), pharyngitis (1.9%), epistaxis (1.4%), and pleuritis (1.1%). Abnormal breath sounds, pneumothorax, pneumonia, pleural effusion, rhinitis, dyspnea, pneumonitis, sinusitis, increased sputum, pulmonary fibrosis, upper respiratory congestion, asthma, abnormal chest x-ray, bronchospasm, laryngeal edema, laryngitis, and respiratory disorder have been reported in less than 1% of patients.

Immunologic

Immunologic side effects have included influenza (7.8%), tuberculosis infection (2.5%), infection (1.4%), and herpes zoster (1.1%). Fungal infection, parasitic infection, and protozoan infection have been reported in less than 1% of patients.

Hepatic

Hepatic side effects have included elevated ALT (6.9%) and AST (5.8%). Bilirubinemia, hepatomegaly, jaundice, and hepatitis have been reported in less than 1% of patients.

Other

Other side effects have included back pain (6.9%), pain (6.1%), chest pain (5.5%), accident injury (4.7%), abdominal pain (1.9%), fever (1.4%), fatigue (1.1%), dependent edema (1.1%), at least one case of influenza-like syndrome, and orange-red discoloration of body tissues and/or fluids (e.g., skin, teeth, tongue, urine, tears, sputum, saliva, feces, sweat, and cerebral spinal fluid). Abnormal laboratory test, legs edema, asthenia, face edema, abscess, peripheral edema, malaise, ear disorder not specified, otitis media, earache, otitis externa, and tympanic membrane perforation have been reported in less than 1% of patients.

Dermatologic

Dermatologic side effects have included increased sweating (6.4%), rash (6.1%), pruritus (3.6%), acne (2.5%), skin disorder (1.4%), maculopapular rash (1.7%), and eczema (1.1%). Skin ulceration, urticaria, dry skin, furunculosis, skin discoloration, fungal dermatitis, nail disorder, alopecia, and erythematous rash have been reported in less than 1% of patients.

Gastrointestinal

Clostridium difficile should be suspected in any patient who develops persistent or severe diarrhea following rifapentine therapy.

Gastrointestinal side effects have included anorexia (5.8%), nausea (2.5%), vomiting (2.5%), dyspepsia (2.8%), constipation (1.9%), diarrhea (1.9%), and hemorrhoids (1.4%). Tooth disorder, gastroenteritis, gastritis, esophagitis, cheilitis, dry mouth, pancreatitis, proctitis, salivary gland enlargement, tenesmus, and gastrointestinal disorder not specified have been reported in less than 1% of patients. Clostridium difficile associated diarrhea has been reported with almost all antibiotics, including the rifamycins.

Nervous system

Nervous system side effects have included headache (3.9%), dizziness (1.7%), tremor (1.4%), and insomnia (1.1%). Somnolence, seizure not specified, dysphonia, hypoesthesia, torticollis, hypertonia, hyporeflexia, meningitis, migraine headache, stupor, and taste loss have been reported in less than 1% of patients.

Musculoskeletal

Musculoskeletal side effects have included arthralgia (4.4%), arthritis (1.1%), arthrosis (1.1%), and gout (1.1%). Myalgia, myositis, bone fracture, muscle weakness, and muscle spasm have been reported in less than 1% of patients.

Cardiovascular

Cardiovascular side effects have included hypertension (1.7%). Syncope, tachycardia, palpitation, orthostatic hypotension, pericarditis, deep thrombophlebitis, vascular disorder, and vasodilation have been reported in less than 1% of patients.

Ocular

Ocular side effects have included conjunctivitis (2.5%). Eye pain and eye abnormality have been reported in less than 1% of patients.

Psychiatric

Psychiatric side effects have included anxiety, confusion, drug abuse, aggressive reaction, and agitation in less than 1% of patients.

Oncologic

Oncologic side effects have included pulmonary carcinoma, neoplasm not specified, carcinoma, and lipoma in less than 1% of patients.

Renal

Renal side effects have included increased BUN (less than 1%).

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