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Priftin

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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

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.

Active Pulmonary Tuberculosis

PRIFTIN was studied in a randomized, open label, active-controlled trial of HIV-negative patients with active pulmonary tuberculosis. The population consisted of primarily of male subjects with a mean age of 37 ± 11 years. In the initial 2 month phase of treatment, 361 patients received PRIFTIN 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 known. During the 4 month continuation phase, 317 patients in the PRIFTIN group continued to receive PRIFTIN 600 mg dosed once-weekly with isoniazid and 304 patients in the rifampin group received twice weekly rifampin and isoniazid. Both treatment groups received pyridoxine (Vitamin B6) over the 6 month treatment period.

Because PRIFTIN was administered as part of a combination regimen, the adverse reaction profile reflects the entire regimen.

Twenty-two deaths occurred in the study, eleven in the rifampin combination therapy group and eleven in the PRIFTIN combination therapy group. 18/361 (5%) rifampin combination therapy patients discontinued the study due to an adverse reaction compared to 11/361 (3%) PRIFTIN combination therapy patients. Three patients (two rifampin combination therapy patients and one PRIFTIN combination therapy patient) were discontinued in the initial phase due to hepatotoxicity. Concomitant medications for all three patients included isoniazid, pyrazinamide, ethambutol, and pyridoxine. All three recovered without sequelae.

Five patients had adverse reactions associated with PRIFTIN overdose. These reactions included hematuria, neutropenia, hyperglycemia, ALT increased, hyperuricemia, pruritus, and arthritis.

Table 2 presents selected treatment-emergent adverse reactions associated with the treatment regimens which occurred in at least 1% of patients during treatment and post-treatment through the first three months of follow-up.

Table 2: Selected Treatment Emergent Adverse Reactions During Treatment of Active Pulmonary Tuberculosis and Through Three Months Follow-up

System Organ Class Preferred Term Initial Phase1 Continuation Phase2
PRIFTIN Combination
(N=361)
N (%)
Rifampin Combination
(N=361)
N (%)
PRIFTIN Combination
(N=317)
N (%)
Rifampin Combination
(N=304)
N (%)
BLOOD AND LYMPHATICS
Anemia 41 (11.4) 41 (11.4) 5 (1.6) 10 (3.3)
Lymphopenia 38 (10.5) 37 (10.2) 10 (3.2) 9 (3.)
Neutropenia 22 (6.1) 21 (5.8) 27 (8.5) 24 (7.9)
Leukocytosis 6 (1.7) 13 (3.6) 5 (1.6) 2 (0.7)
Thrombocytosis 20 (5.5) 13 (3.6) 1 (0.3) 0 (0.0)
Thrombocytopenia 6 (1.7) 6 (1.7) 4 (1.3) 6 (2)
Lymphadenopathy 4 (1.1) 2 (0.6) 0 (0.0) 2 (0.7)
Nonprotein Nitrogen Increased 4 (1.1) 3 (0.8) 10 (3.2) 15 (4.9)
EYE
Conjunctivitis 8 (2.2) 2 (0.6) 1 (0.3) 1 (0.3)
GASTROINTESTINAL
Dyspepsia 6 (1.7) 11 (3) 4 (1.3) 6 (2)
Vomiting 6 (1.7) 14 (3.9) 3 (0.9) 3 (1)
Nausea 7 (1.9) 3 (0.8) 2 (0.6) 1 (0.3)
Diarrhea 5 (1.4) 2 (0.6) 2 (0.6) 0 (0.0)
GENERAL
Back Pain 15 (4.2) 11 (3) 11 (3.5) 4 (1.3)
Abdominal Pain 3 (0.8) 3 (0.8) 4 (1.3) 4 (1.3)
Fever 5 (1.4) 7 (1.9) 1 (0.3) 1 (0.3)
Anorexia 14 (3.9) 18 (5) 8 (2.5) 6 (2)
HEPATIC & BILIARY
ALT Increased 18 (5) 23 (6.4) 7 (2.2) 10 (3.3)
AST Increased 15 (4.2) 18 (5) 7 (2.2) 8 (2.6)
MUSCULOSKELETAL
Arthralgia 13 (3.6) 13 (3.6) 3 (0.9) 5 (1.6)
NEUROLOGIC
Headache 11 (3) 13 (3.6) 3 (0.9) 7 (2.3)
Dizziness 5 (1.4) 5 (1.4) 1 (0.3) 1 (0.3)
RESPIRATORY
Hemoptysis 27 (7.5) 20 (5.5) 6 (1.9) 6 (2)
Coughing 21 (5.8) 8 (2.2) 9 (2.8) 11 (3.6)
SKIN
Rash 15 (4.2) 26 (7.2) 8 (2.5) 8 (2.6)
Sweating Increased 19 (5.3) 18 (5) 5 (1.6) 4 (1.3)
Pruritus 10 (2.8) 16 (4.4) 3 (0.9) 0 (0.0)
Rash Maculopapular 6 (1.7) 3 (0.8) 0 (0.0) 1 (0.3)
1Initial phase consisted of therapy with either PRIFTIN twice weekly or rifampin daily combined with daily isoniazid, pyrazinamide, and ethambutol for 60 days.
2Continuation phase consisted of therapy with either PRIFTIN once weekly or rifampin twice weekly combined with daily isoniazid for 120 days.

The following selected treatment-emergent adverse reactions were reported in less than 1% of the PRIFTIN combination therapy patients during treatment and post-treatment through the first three months of follow-up.

Blood and Lymphatics: lymphocytosis, hematoma, purpura, thrombosis.

Cardiovascular: syncope, tachycardia, palpitation, orthostatic hypotension, pericarditis.

Metabolic & Nutritional: BUN increased, alkaline phosphatase increased.

Gastrointestinal: gastritis, esophagitis, pancreatitis, salivary gland enlargement.

General: asthenia, facial edema.

Hepatobiliary: bilirubinemia, hepatomegaly, jaundice.

Infectious Disease: infection fungal.

Musculoskeletal: myalgia, myositis.

Neurologic: somnolence, dysphonia.

Pregnancy, Puerperium and Perinatal conditions: abortion

Psychiatric: anxiety, confusion

Reproductive Disorders: vaginitis, vaginal hemorrhage, leukorrhea.

Respiratory: dyspnea, pneumonitis, pulmonary fibrosis, asthma, bronchospasm, laryngeal edema, laryngitis.

Skin: urticaria, skin discoloration,

In another randomized, open-label trial, 1075 HIV non-infected and infected patients with active pulmonary tuberculosis who had completed an initial 2 month phase of treatment with 4 drugs were randomly assigned to receive either PRIFTIN 600 mg and isoniazid once weekly or rifampin and isoniazid twice weekly for the 4 month continuation phase. 502 HIV non-infected and 36 HIV-infected patients were randomized to receive the PRIFTIN regimen and 502 HIVnoninfected and 35 HIV-infected patients were randomized to receive the rifampin regimen. The death rate was 6.5% for the PRIFTIN combination regimen compared to 6.7% for the rifampin combination regimen.

Latent Tuberculosis Infection

Main Study

PRIFTIN in combination with isoniazid given once-weekly for 3 months (3RPT/INH) was compared to isoniazid given once daily for 9 months (9INH) in an open-label, randomized trial in patients with a positive tuberculin skin test, and at high risk for progression from latent tuberculosis infection to active tuberculosis disease. PRIFTIN was dosed by weight, and isoniazid mg/kg dose was determined according to age [see DOSING AND ADMINISTRATION] to a maximum of 900 mg each.

A total of 4040 patients received at least one dose of the 3RPT/INH regimen, including 348 children 2-17 years of age and 105 HIV-infected individuals. A total of 3759 received at least one dose of the 9INH regimen, including 342 children 2 years-17 years of age and 95 HIV-infected individuals.

Patients were followed for 33 months from the time of enrollment. Treatment-emergent adverse reactions were defined as those occurring during treatment and 60 days after the last dose of treatment. 161 (4%) 3RPT/INH subjects had a rifamycin hypersensitivity reaction, defined as either: a) one of the following: hypotension, urticaria, angioedema, acute bronchospasm, or conjunctivitis occurring in relation to study drug or b) at least four of the following symptoms occurring in relation to the study drug, with at least one symptom being CTCAE Grade 2 or higher: weakness, fatigue, nausea, vomiting, headache, fever, aches, sweats, dizziness, shortness of breath, flushing or chills. No specific definition was used for isoniazid hypersensitivity; 18 (0.5%) 9INH subjects were classified as having a hypersensitivity reaction. Hepatotoxicity was defined as AST ≥ 3x upper limit of normal in the presence of specific signs and symptoms of hepatitis, or AST > 5x upper limit of normal regardless of signs or symptoms. 113 (3%) 9INH subjects and 24 (0.6%) 3RPT/INH subjects developed hepatotoxicity.

196 subjects (4.9%) in the 3RPT/INH arm discontinued treatment due to a treatment related adverse reaction patients and 142 (3.8%) in the 9INH arm discontinued treatment due to a treatment related adverse reaction. In the 3RPT/INH group, the most frequent treatment related adverse reaction resulting in treatment discontinuation was hypersensitivity reaction, occurring in 120 (3%) patients. In the 9INH group, the most frequent treatment related adverse reaction resulting in treatment discontinuation was hepatotoxicity, occurring in 76 (2%) patients.

Seventy one deaths occurred, 31/4040, 0.77% in the 3RPT/INH group and 40/3759 (1.06%) in the 9INH group) during the 33 month study period. During the treatment emergent period, 11 deaths occurred, 4 in the 3RPT/INH group and 7 in the 9INH group. None of the reported deaths were considered related to treatment with study drugs or were attributed to tuberculosis disease.

Table 3 presents select adverse reactions that occurred during the treatment emergent period in the main study in LTBI patients treated with 3RPT/INH or 9INH at a frequency greater than 0.5%.

Table 3 : Select Adverse Reactions occurring in 0.5% or greater of patients* in the Latent Tuberculosis Infection Main Study

System Organ Class Preferred Term 3RPT/INH
(N=4040)
N (%)
9INH
(N=3759)
N (%)
Immune system disorders
Hypersensitivity 161 (4) 18 (0.5)
Hepatobiliary disorders
Hepatitis 24 (0.6) 113 (3)
Nervous system disorders
Headache 26 (0.6) 17 (0.5)
Skin and subcutaneous tissue disorders
Skin reaction 31 (0.8) 21 (0.6)
*Includes events reported through 60 days after last dose of study drug

Pediatric Substudy

Six-hundred and ninety children 2 years-17 years of age received at least one dose of study drugs in the main study. An additional 342 children 2 years-17 years of age received at least one dose in the pediatric extension study (total 1032 children; 539 received 3RPT/INH and 493 received 9INH).

No children in either treatment arm developed hepatotoxicity. Using the same definition for rifamycin hypersensitivity reaction as in the main study, 7 (1.3%) of children in the 3RPT/INH group experienced a rifamycin hypersensitivity reaction. Adverse reactions in children 2 years11 years of age and 12 years-17 years of age were similar.

HIV Substudy

Two-hundred HIV-infected patients with latent tuberculosis infection received at least one dose of study drugs in the main study and an additional 193 patients received at least one dose in the extension study (total of 393; 207 received 3RPT/INH and 186 received 9INH). Compared to the HIV-negative patients enrolled in the main study, a higher proportion of HIV-infected patients in each treatment arm experienced a treatment emergent adverse reaction, including a higher incidence of hepatotoxicity. Hepatotoxicity occurred in 3/207 (1.5%) patients in the 3RPT/INH arm and in 14/186 (7.5%) in the 9INH arm. Rifamycin hypersensitivity occurred in only one HIV-infected patient.

Eleven deaths occurred during the 33 month follow up period (6/207 in the 3RPT/INH group and 5/186 in the 9INH group) including one death in the 9INH arm during the treatment emergent period. None of the reported deaths were considered related to treatment with study drugs or tuberculosis disease.

Selected treatment-emergent adverse reactions reported during treatment and 60 days posttreatment in less 0.5% of the 3RPT/INH combination-therapy group in the main study are presented below by body system.

Eye Disorders: conjunctivitis.

Blood and Lymphatic System Disorders: leukopenia, anemia, lymphadenopathy, neutropenia.

Gastrointestinal Disorders: nausea, diarrhea, vomiting, abdominal pain constipation, dry mouth, dyspepsia, esophageal irritation, gastritis, pancreatitis.

General Disorders and Administration Site Conditions: fatigue, pyrexia, asthenia, chest pain, chills, feeling jittery.

Infections and Infestations: pharyngitis, viral infection, vulvovaginal candidiasis.

Metabolism and Nutrition Disorders: hyperglycemia, gout, hyperkalemia, decreased appetite, hyperlipidemia.

Musculoskeletal and Connective Tissue Disorders: arthralgia, myalgia, back pain, rhabdomyolysis.

Nervous system Disorders: dizziness, convulsion, paresthesia, headache, neuropathy peripheral, syncope.

Psychiatric Disorders: depression, anxiety, disorientation, suicidal ideation.

Renal and Urinary Disorders: azotemia.

Reproductive System and Breast Disorders: vulvovaginal pruritus.

Respiratory, Thoracic and Mediastinal Disorders: cough, dyspnea, oropharyngeal pain, asthma, bronchial hyperactivity, epistaxis.

Skin and Subcutaneous Tissue Disorders: rash, hyperhidrosis, pruritus, urticaria.

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

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