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Priftin

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Priftin

Priftin

Priftin Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Priftin (rifapentine) is used together with other antibiotics to treat tuberculosis. It is an antibiotic. Common side effects include stomach upset, nausea, vomiting, loss of appetite, or headache.

Priftin is administered at a dose of 600 mg (4 x 150 mg tablets) twice weekly for two months, with an interval of no less than 3 days (72 hours) between doses, in combination with other antituberculosis drugs as part of a regimen which includes daily companion drugs such as ethambutol, pyrazinamide, and streptomycin. Priftin may interact with HIV/AIDS medications including, abacavir, amprenavir, delavirdine, didanosine, efavirenz, indinavir, lamivudine, nelfinavir, nevirapine, ritonavir, saquinavir, stavudine, zalcitabine, or zidovudine. Tell your doctor all medications and supplements you use. During pregnancy, Priftin should be used only when prescribed. When this drug is taken during the last few weeks of pregnancy, the risk of bleeding in both mother and infant may be increased. Tell your doctor if you notice any bleeding in your newborn. It is unknown if this drug passes into breast milk. Similar drugs pass into breast milk. Consult your doctor before breastfeeding.

Our Priftin (rifapentine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Priftin in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • blood in your urine;
  • pale skin, weakness, easy bruising or bleeding; or
  • fever, chills, body aches, flu symptoms.

Less serious side effects may include:

  • red, orange, or brown discoloration of your skin, tears, sweat, saliva, urine, or stools;
  • nausea, vomiting, diarrhea, loss of appetite;
  • stomach pain;
  • headache;
  • joint pain; or
  • mild skin rash or itching.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Priftin (Rifapentine) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Priftin Overview - Patient Information: Side Effects

SIDE EFFECTS: Stomach upset, nausea, vomiting, loss of appetite, or headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

This medication may cause urine, sweat, saliva, or tears to turn reddish. This effect is harmless and will disappear when the medication is stopped. However, dentures and contact lenses may be permanently stained.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: symptoms of liver disease (such as persistent nausea/vomiting, unusual tiredness/weakness, severe stomach/abdominal pain, yellowing eyes/skin, dark urine), painful/swollen joints, dark/bloody urine, easy bleeding/bruising, unusual tiredness, signs of a new infection (such as fever, persistent sore throat).

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Priftin (Rifapentine)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Priftin FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Serious and Otherwise Important Adverse Reactions

The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data described below reflect exposure to PRIFTIN (rifapentine) in a randomized, open label, active-controlled trial of patients with pulmonary tuberculosis, excluding those with HIV-infection. The population consisted of primarily of male subjects with a mean age of 37 11 years. In the initial 2 month phase of treatment (60 days), 361 patients received rifapentine 600 mg twice a week in combination with daily isoniazid, pyrazinamide, and ethambutol and 361 subjects received rifampin in combination with isoniazid, pyrazinamide and ethambutol all administered daily. Ethambutol was discontinued when drug susceptibly testing was completed. During the 4 month continuation phase, 321 patients in the rifapentine group continued to receive rifapentine 600 mg dosed once weekly with isoniazid and 307 patients in the rifampin arm received twice weekly rifampin and isoniazid. Both treatment groups received pyridoxine (Vitamin B6) over the 6 month treatment period.

Twenty-two deaths occurred in the study (eleven in the rifampin combination therapy group and eleven in the rifapentine combination therapy group).

In the study, 18/361 (5.0%) rifampin combination therapy patients discontinued the study due to an adverse reaction compared to 11/361 (3.0%) rifapentine combination therapy patients. Three patients (two rifampin combination therapy patients and one rifapentine combination therapy patient) were discontinued in the Initial Phase as a result of hepatitis with increased liver function tests (ALT, AST, LDH, and bilirubin). Concomitant medications for all three patients included isoniazid, pyrazinamide, ethambutol, and pyridoxine. The two rifampin patients and one rifapentine patient recovered without sequelae.

As shown in Table 1, hyperuricemia was the most frequently reported reaction and was most likely related to the pyrazinamide since only two cases were reported in the Continuation Phase when this drug was no longer included in the treatment regimen.

Seven patients had adverse reactions associated with an overdose. In the rifampin combination group these reactions included hematuria, anorexia, back pain, arthralgia, and myalgia. In the rifapentine combination group these reactions included hematuria, neutropenia, hyperglycemia, ALT increased, hyperuricemia, pruritus, and arthritis.

The following table (Table 1) presents treatment-emergent adverse reactions associated with the use of any of the four drugs in the regimens (rifapentine/rifampin, isoniazid, pyrazinamide, or ethambutol) which occurred in ≥ 1% of patients during treatment and post-treatment through the first three months of follow-up.

Table 1. Treatment-Emergent Adverse Reactions Occurring in ≥ 1% of Patients

System Organ Class Preferred Term Initial Phase1 Continuation Phase2 Total3
Rifapentine Combination (N=361) N(%) Rifampin Combination (N=361) N(%) Rifapentine Combination (N=304) N(%) Rifampin Combination (N=317) N(%) Rifapentine Combination (N=361) N(%) Rifampin Combination (N=361) N(%)
RENAL & URINARY
Pyuria 39 (10.8) 56 (15.5) 47 (14.8) 36 (11.8) 78 (21.6) 83 (23.0)
Proteinuria 36 (10.0) 53 (14.7) 14 (4.4) 27 (8.9) 47 (13.0) 71 (19.7)
Hematuria 39 (10.8) 38 (10.5) 32 (10.1) 27 (8.9) 64 (17.7) 61 (16.9)
Urinary Tract Infection 32 (8.9) 24 (6.6) 23 (7.3) 10 (3.3) 48 (13.3) 32 (8.9)
Urinary Casts 20 (5.5) 22 (6.1) 11 (3.5) 7 (2.3) 29 (8.0) 28 (7.8)
Cystitis 5(1.4) 6 (1.7) 1 (0.3) 1 (0.3) 6 (1.7) 7(1.9)
METABOLIC & NUTRITIONAL
Hyperuricemia 115 (31.9) 83 (23.0) 0 (0.0) 2 (0.7) 115 (31.9) 83 (23.0)
Hyperkalemia 14 (3.9) 22 (6.1) 20 (6.3) 21 (6.9) 33 (9.1) 41 (11.4)
Hypoglycemia 22 (6.1) 27 (7.5) 15 (4.7) 11 (3.6) 36 (10.0) 35 (9.7)
Nonprotein Nitrogen Increased 4(1.1) 3 (0.8) 10 (3.2) 15 (4.9) 14 (3.9) 17 (4.7)
Hyperglycemia 10 (2.8) 8 (2.2) 4(1.3) 2 (0.7) 13 (3.6) 9 (2.5)
LDH Increased 5 (1.4) 7(1.9) 0 (0.0) 2 (0.7) 5 (1.4) 9 (2.5)
Hyperphosphatemia 2 (0.6) 1 (0.3) 3 (0.9) 5 (1.6) 5 (1.4) 6 (1.7)
HEMATOLOGIC
Anemia 41 (11.4) 41 (11.4) 5 (1.6) 10 (3.3) 44 (12.2) 51 (14.1)
Lymphopenia 38 (10.5) 37 (10.2) 10 (3.2) 9 (3.0) 46 (12.7) 45 (12.5)
Neutropenia 22 (6.1) 21 (5.8) 27 (8.5) 24 (7.9) 45 (12.5) 41 (11.4)
Leukopenia 16 (4.4) 11 (3.0) 11 (3.5) 9 (3.0) 24 (6.6) 17 (4.7)
Leukocytosis 6 (1.7) 13 (3.6) 5 (1.6) 2 (0.7) 11 (3.0) 15 (4.2)
Neutrophilia 5 (1.4) 11 (3.0) 4 (1.3) 2 (0.7) 9 (2.5) 13 (3.6)
Thrombocytosis 20 (5.5) 13 (3.6) 1 (0.3) 0 (0.0) 20 (5.5) 13 (3.6)
Thrombocytopenia 6 (1.7) 6 (1.7) 4 (1.3) 6 (2.0) 9 (2.5) 11 (3.0)
Polycythemia 3 (0.8) 2 (0.6) 5 (1.6) 3 (1.0) 8 (2.2) 5 (1.4)
Lymphadenopathy 4(1.1) 2 (0.6) 0 (0.0) 2 (0.7) 4(1.1) 4(1.1)
BODY AS A WHOLE -GENERAL
Back Pain 15 (4.2) 11 (3.0) 11 (3.5) 4 (1.3) 25 (6.9) 15 (4.2)
Pain 14 (3.9) 17 (4.7) 8 (2.5) 5 (1.6) 22 (6.1) 22 (6.1)
Chest Pain 10 (2.8) 11 (3.0) 10 (3.2) 5 (1.6) 20 (5.5) 16 (4.4)
Injury Accident 5 (1.4) 5 (1.4) 12 (3.8) 14 (4.6) 17 (4.7) 17 (4.7)
Abdominal Pain 3 (0.8) 3 (0.8) 4 (1.3) 4 (1.3) 7(1.9) 7(1.9)
Fever 5 (1.4) 7(1.9) 1 (0.3) 1 (0.3) 5 (1.4) 7(1.9)
Fatigue 3 (0.8) 1 (0.3) 1 (0.3) 3 (1.0) 4(1.1) 4(1.1)
Edema Dependent 4(1.1) 1 (0.3) 0 (0.0) 1 (0.3) 4(1.1) 2 (0.6)
DERMATOLOGIC
Rash 15 (4.2) 26 (7.2) 8 (2.5) 8 (2.6) 22 (6.1) 33 (9.1)
Sweating Increased 19 (5.3) 18 (5.0) 5 (1.6) 4 (1.3) 23 (6.4) 22 (6.1)
Pruritus 10 (2.8) 16 (4.4) 3 (0.9) 0 (0.0) 13 (3.6) 16 (4.4)
Acne 9 (2.5) 5 (1.4) 0 (0.0) 3 (1.0) 9 (2.5) 8 (2.2)
Skin Disorder 2 (0.6) 3 (0.8) 3 (0.9) 5 (1.6) 5 (1.4) 8 (2.2)
Rash Maculopapular 6 (1.7) 3 (0.8) 0 (0.0) 1 (0.3) 6 (1.7) 4(1.1)
Eczema 2 (0.6) 2 (0.6) 3 (0.9) 2 (0.7) 4(1.1) 3 (0.8)
RESPIRATORY
Hemoptysis 27 (7.5) 20 (5.5) 6 (1.9) 6 (2.0) 30 (8.3) 25 (6.9)
Coughing 21 (5.8) 8 (2.2) 9 (2.8) 11 (3.6) 29 (8.0) 17 (4.7)
Upper Respiratory Tract Infection 5 (1.4) 9 (2.5) 12 (3.8) 15 (4.9) 17 (4.7) 22 (6.1)
Bronchitis 1 (0.3) 1 (0.3) 8 (2.5) 1 (0.3) 9 (2.5) 2 (0.6)
Pharyngitis 5 (1.4) 0 (0.0) 2 (0.6) 5(1.6) 7(1.9) 5 (1.4)
Epistaxis 2 (0.6) 2 (0.6) 3 (0.9) 1 (0.3) 5 (1.4) 3 (0.8)
Pleuritis 4 (1.1) 1 (0.3) 0 (0.0) 1 (0.3) 4(1.1) 2 (0.6)
GASTROINTESTINAL
Dyspepsia 6 (1.7) 11 (3.0) 4(1.3) 6 (2.0) 10 (2.8) 17 (4.7)
Vomiting 6 (1.7) 14 (3.9) 3 (0.9) 3 (1.0) 9 (2.5) 17 (4.7)
Nausea 7 (1.9) 3 (0.8) 2 (0.6) 1 (0.3) 9 (2.5) 4(1.1)
Constipation 6 (1.7) 1 (0.3) 2 (0.6) 1 (0.3) 7(1.9) 2 (0.6)
Diarrhea 5 (1.4) 2 (0.6) 2 (0.6) 0 (0.0) 7(1.9) 2 (0.6)
Hemorrhoids 4 (1.1) 0 (0.0) 1 (0.3) 0 (0.0) 5 (1.4) 0 (0.0)
INFECTIOUS DISEASE
Influenza 9 (2.5) 8 (2.2) 22 (6.9) 12 (3.9) 28 (7.8) 20 (5.5)
Infection Tuberculosis 0 (0.0) 5 (1.4) 9 (2.8) 4 (1.3) 9 (2.5) 9 (2.5)
Infection 1 (0.3) 2 (0.6) 4(1.3) 4(1.3) 5 (1.4) 6 (1.7)
Herpes Zoster 2 (0.6) 0 (0.0) 2 (0.6) 3 (1.0) 4(1.1) 3 (0.8)
HEPATIC & BILIARY
ALT Increased 18 (5.0) 23 (6.4) 7(2.2) 10 (3.3) 25 (6.9) 32 (8.9)
AST Increased 15 (4.2) 18 (5.0) 7 (2.2) 8 (2.6) 21 (5.8) 26 (7.2)
NEUROLOGIC
Headache 11 (3.0) 13 (3.6) 3 (0.9) 7 (2.3) 14 (3.9) 20 (5.5)
Dizziness 5 (1.4) 5 (1.4) 1 (0.3) 1 (0.3) 6 (1.7) 6 (1.7)
Tremor 3 (0.8) 1 (0.3) 2 (0.6) 0 (0.0) 5 (1.4) 1 (0.3)
PSYCHIATRIC
Anorexia 14 (3.9) 18 (5.0) 8 (2.5) 6 (2.0) 21 (5.8) 22 (6.1)
Insomnia 2 (0.6) 2 (0.6) 2 (0.6) 2 (0.7) 4 (1.1) 4(1.1)
MUSCULOSKELETAL
Arthralgia 13 (3.6) 13 (3.6) 3 (0.9) 5 (1.6) 16 (4.4) 18 (5.0)
Arthritis 4 (1.1) 5 (1.4) 1 (0.3) 0 (0.0) 4(1.1) 5 (1.4)
Arthrosis 4 (1.1) 1 (0.3) 0 (0.0) 1 (0.3) 4(1.1) 2 (0.6)
Gout 3 (0.8) 1 (0.3) 1 (0.3) 0 (0.0) 4(1.1) 1 (0.3)
CARDIOVASCULAR
Hypertension 3 (0.8) 5 (1.4) 3 (0.9) 2 (0.7) 6 (1.7) 7(1.9)
OPHTHALMOLOGIC
Conjuctivitis 8 (2.2) 2 (0.6) 1 (0.3) 1 (0.3) 9 (2.5) 3 (0.8)
Note: ≥ 1% refers to rifapentine in the TOTAL column.
1 Initial Phase consisted of therapy with either rifapentine or rifampin combined with isoniazid, pyrazinamide, and ethambutol administered daily (rifapentine twice weekly) for 60 days.
2 Continuation Phase consisted of therapy with either rifapentine or rifampin combined with isoniazid for 120 days. Rifapentine patients were dosed once weekly; rifampin patients were dosed twice weekly.
3 A patient may have experienced the same adverse reaction more than once during the course of the study, therefore, patient counts across the columns may not equal the patient counts in the TOTAL column.

In addition to the adverse reactions reported in Table 1, adverse reactions were reported post-treatment during the 3 month through 24 month follow-up period. Although the protocol for this study specified collection of serious adverse reactions during this period, some non-serious adverse reactions were reported as well. For the rifapentine combination group these included the following: hematuria, infection tuberculosis, proteinuria, urinary casts, hyperkalemia, hypoglycemia, injury accident, skin disorder, respiratory disorder, stupor, prostatic disorder.

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).

Read the entire FDA prescribing information for Priftin (Rifapentine) »

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