Priftin

• Priftin^®

Rifapentine is an antibiotic that fights bacteria.

Rifapentine is used together with other medicines to treat active tuberculosis (TB) in adults and children who are at least 12 years old.

Rifapentine is also used to keep inactive (latent) TB from becoming active in adults and children who are at least 2 years old.

Rifapentine must always be used in combination with other tuberculosis medications.

Rifapentine may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

You should not take this medicine if you are allergic to rifapentine, rifabutin (Mycobutin), or rifampin (Rifadin, Rifater, Rimactane, Rifamate).

To make sure rifapentine is safe for you, tell your doctor if you have:

• liver disease;
• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);
• HIV or AIDS;
• if you have used rifampin or isoniazid in the past and they were not effective in treating TB; or
• if you have been exposed to someone with TB that could not be treated with rifampin or isoniazid.

FDA pregnancy category C. It is not known whether rifapentine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

Rifapentine can make birth control pills less effective. Ask your doctor about using non hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy while taking rifapentine.

It is not known whether rifapentine passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine. Rifapentine may cause a red-orange discoloration of breast milk.

Do not give this medicine to a child without medical advice.

You should not take this medication if you are allergic to rifapentine, rifabutin (Mycobutin), or rifampin (Rifadin, Rifater, Rimactane, Rifamate).

Before taking rifapentine, tell your doctor if you have porphyria.

Rifapentine should not be used without other antibiotics. Be sure to take all your medications as prescribed by your doctor.

Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.

Rifapentine can make birth control pills less effective. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking rifapentine.

Do not wear dentures or contact lenses while taking rifapentine. This medicine may discolor certain body fluids (including tears and saliva) with a red, orange, or brown color. While this is a harmless side effect, it may permanently stain a pair of contact lenses.

Rifapentine is an antibiotic that fights bacteria.

Rifapentine is used together with other medicines to treat active tuberculosis (TB) in adults and children who are at least 12 years old.

Rifapentine is also used to keep inactive (latent) TB from becoming active in adults and children who are at least 2 years old.

Rifapentine must always be used in combination with other tuberculosis medications.

Rifapentine may also be used for purposes not listed in this medication guide.

In the U.S.

• Priftin

Available Dosage Forms:

• Tablet

Therapeutic Class: Antitubercular

Chemical Class: Rifamycin

Priftin (rifapentine) for oral administration contains 150 mg of the active ingredient rifapentine per tablet.

The 150 mg tablets also contain, as inactive ingredients: calcium stearate, disodium EDTA, FD&C Blue No. 2 aluminum lake, hydroxypropyl cellulose, hypromellose USP, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, propylene glycol, sodium ascorbate, sodium lauryl sulfate, sodium starch glycolate, synthetic red iron oxide, and titanium dioxide.

Rifapentine is a rifamycin derivative antimicrobial and has a similar profile of microbiological activity to rifampicin. The molecular weight is 877.04.

The molecular formula is C47H64N4O12.

The chemical name for rifapentine is rifamycin, 3-[[(4-cyclopentyl-1-piperazinyl)imino]methyl]- or 3-[N-(4-cyclopentyl-1-piperazinyl)formimidoyl]rifamycin or 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18,20,22-heptamethyl-8-[N-(4-cyclopentyl-l-piperazinyl)-formimidoyl]-2,7-(epoxypentadeca[1,11,13]trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. It has the following structure:

1. Clinical and Laboratory Standards Institute. M24-A Susceptibility Testing of Mycobacteria, Nocardiae, and Other Aerobic Actinomycetes; Approved Standard. 23 ed. 2003. Clinical Laboratory Standards Institute, Wayne, PA.

Applies to rifapentine: oral tablet

Along with its needed effects, rifapentine (the active ingredient contained in Priftin) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking rifapentine:

• Blood in the urine
• joint pain
• lower back or side pain
• swelling of the feet or lower legs

• Aggressive reaction
• black, tarry stools
• blood in the stools
• nausea
• pinpoint red spots on the skin
• severe abdominal or stomach pain
• sore throat and fever
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting
• yellow eyes or skin

• Diarrhea
• dizziness
• increase in blood pressure
• severe or continuing headaches

Some side effects of rifapentine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Acne
• constipation
• loss of appetite

In one clinical study, six patients randomized to rifapentine became pregnant during treatment. There were 2 normal deliveries, 2 first trimester spontaneous abortions, one elective abortion, and one lost to follow-up. Of the two patients with spontaneous abortions, one had a history of ethanol abuse and the other had HIV infection. When administered during the last few weeks of pregnancy, rifampin, a chemically related agent, has rarely been associated with maternal and neonatal hemorrhagic complications stemming from vitamin K deficiency. Prophylactic vitamin K is sometimes given, particularly if dietary vitamin K intake is inadequate. If rifapentine is used during the latter weeks of pregnancy, appropriate clotting parameters should be assessed in both patient and neonate.

Rifapentine has been assigned to pregnancy category C. Animal studies using doses similar to or less than the human dose (based on body surface area) have revealed evidence of teratogenicity. There are no controlled studies in human pregnancy. Rifapentine should only be given during pregnancy when benefit outweighs risk.

Substance Name

Rifapentine

CAS Registry Number

61379-65-5

Drug Class

Antitubercular Agents

Leprostatic Agents

Rifamycins