Pifeltro Tablets / Film-coated
Doravirine
100 mg
Merck Sharp & Dohme B.V.
| Pack size | 30's HDPE Bottle |
|---|---|
| Dispensing mode | POM |
| Source | NETHERLANDS |
| Agent | CITY MEDICAL STORE |
| Retail Price | 2220.50 AED |
Indications
Pifeltro Tablets / Film-coated is used for:
HIV Infection
Adult Dose
HIV Infection
Indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naïve adults
1 tablet PO qDay
Child Dose
<18 years: Safety and efficacy not established
Renal Dose
Administration
Administer at a regularly scheduled time with or without food
Contra Indications
Strong CYP3A4 inducers
Coadministered with strong CYP3A inducers, as significant decreases in doravirine plasma concentrations may occur, which may decrease the efficacy of doravirine
Strong CYP3A inducer examples include carbamazepine, oxcarbazepine, phenobarbital, phenytoin, enzalutamide, rifampin, rifapentine, mitotane, and St. John’s wort
Precautions
Immune reconstitution syndrome reported in patients treated with combination antiretroviral therapy; patients may develop an inflammatory response to indolent or residual opportunistic infections (such as Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia (PCP), or tuberculosis), which may necessitate further evaluation and treatment
Autoimmune disorders (eg, Grave disease, polymyositis, Guillain-Barré syndrome) reported to occur in the setting of immune reconstitution; however, time to onset varies and can occur many months after initiation of treatment
Pregnancy-Lactation
Pregnancy
Data are not available to establish drug-associated risks to pregnancy outcomes
Animal data
In animal reproduction studies, no adverse developmental effects were observed when doravirine was administered at exposures ?8 times the exposure in humans at the recommended human dose (RHD)
Lactation
The Centers for Disease Control and Prevention do not recommend HIV-infected women breastfeed their infants, owing to potential risk for postnatal transmission of HIV
Unknown if distributed in human breast milk
Owing to the potential for HIV transmission (in HIV-negative infants), developing viral resistance (in HIV-positive infants), and adverse reactions in a breastfed infant similar to those seen in adults, instruct women not to breastfeed while taking this medication
Interactions
Primarily metabolized by CYP3A; drugs that induce or inhibit CYP3A may affect doravirine clearance
Coadministration with strong CYP3A inducers may decrease systemic exposure and lead to loss of therapeutic effect and possible HIV resistance
Adverse Effects
Side effects of Doravirine :
1-10% (doravirine + 2 NRTIs)
Nausea (7%)
Headache (6%)
Fatigue (6%)
Diarrhea (5%)
Abdominal pain (5%)
Total bilirubin 1.1 to <1.6x ULN (5%)
AST 2.5 to <5x ULN (4%)
Lipase 1.5 to <3x ULN (4%)
Dizziness (3%)
Creatinine >1.3 to 1.8x ULN (3%)
ALT 2.5 to <5x ULN (3%)
Lipase ≥3x ULN (3%)
Creatine kinase ≥10x ULN (3%)
Rash (2%)
Total bilirubin 1.6 to <2.6x ULN (2%)
Creatinine >1.8x ULN (2%)
Creatine kinase 6 to <10x ULN (2%)
Abnormal dreams (1%)
Insomnia (1%)
ALT >5x ULN (1%)
Mechanism of Action
Non-nucleoside reverse transcriptase inhibitor (NNRTI)
Inhibits HIV-1 replication by noncompetitive inhibition of HIV-1 reverse transcriptase
Note
Pifeltro 100 mg Tablets / Film-coated manufactured by Merck Sharp & Dohme B.V.. Its generic name is Doravirine. Pifeltro is availble in United Arab Emirates.
Farmaco UAE drug index information on Pifeltro Tablets / Film-coated is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.