Priftin

Priftin Use In Pregnancy & Lactation

rifapentine

Manufacturer:

Sanofi-Aventis

Distributor:

DKSH
Full Prescribing Info
Use In Pregnancy & Lactation
Pregnancy: Animal data: Animal studies have shown reproductive toxicity in rats and rabbits. A complete reproductive toxicity program was conducted with rifapentine showing drug-related adverse effects in rats and rabbits at 40 mg/kg/day leading to recommendation for use in pregnant and lactating women (see Pharmacology: Toxicology: Preclinical Safety Data under Actions).
Human data: In the clinical trial that compared the safety and effectiveness of rifapentine in combination with isoniazid to isoniazid alone for the treatment of latent tuberculosis infection (TBTC-S26 study), a total of 46 pregnancies were reported in the rifapentine/isoniazid arm. There were 31 live births, six elective abortions, seven spontaneous abortions, and two unknown outcomes. Of the 31 live infants, 21 were reported healthy while in the other ten cases no further details were available. No congenital anomalies were reported. The rate of spontaneous abortion (15%) did not represent an increase over the background rate of 15 to 20 percent reported in the general population. Further interpretation of these results is limited by the quality of adverse event reporting.
In the absence of adequate and well-controlled studies in pregnant women, Priftin should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus.
Rifampicin is known to cause postnatal hemorrhages in the mother and infant when taken during the last few weeks of pregnancy. Since rifapentine might have a similar effect, appropriate coagulation testing should be performed when the drug is used during late pregnancy. Treatment with Vitamin K may be indicated.
Lactation: It is not known whether rifapentine is excreted in human milk.
Animal data have shown compound-related effects in nursing offspring (see Pharmacology: Toxicology: Preclinical Safety Data under Actions). A decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Since rifapentine may produce a red-orange discoloration of body fluids, the potential for discoloration of breast milk should be remembered.
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