Medication info
Pipeltro Tablets (Doravirine)

Pipeltro Tablets (Doravirine)

Prescription medicationTabletOral
Ingredient · strength
Doravirine›100mg / 1 tablet
Manufacturer / importer
MSD KOREA Co., Ltd.
Appearance
White oval tablets engraved with 'MSD logo' and '700' on one side
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201908060 · Approved 2019.11.22 · Insurance code 655502110

Summary

Main use
Combination therapy for HIV-1 infection in adults
Who takes it
Adults
Adult dose
1. Recommended dose Adults should take 1 tablet of 100 mg orally once daily, with or without food. 2. Concomitant administration with rifabutin When this medicine is administered concomitantly with rifabutin, take 1 tablet of this medicine twice daily (approximately 12 hours apart) (see 4. Interactions and 13. Pharmacokinetic Information).

Ingredients

Importer
MSD KOREA Co., Ltd.

Efficacy & effects

Combination therapy for HIV-1 infection in adults

View approved original text

This medication is used in adult HIV-1 infected patients who have not received prior antiretroviral treatment or have maintained stable viral suppression with previous therapies. It is particularly effective in treating HIV infection when combined with other antiretroviral agents in patients without resistance to doravirine. Therefore, this medication is used to control HIV-1 viral load and improve infection management.

How to take

Adult dose

1. Recommended dose Adults should take 1 tablet of 100 mg orally once daily, with or without food. 2. Concomitant administration with rifabutin When this medicine is administered concomitantly with rifabutin, take 1 tablet of this medicine twice daily (approximately 12 hours apart) (see 4. Interactions and 13. Pharmacokinetic Information).

Precautions

This medication should not be taken with certain drugs as it may reduce blood concentration and efficacy. Strong CYP3A enzyme inducers should not be combined with this medication. Medications to avoid with this drug include antiepileptics, certain antituberculars, androgen receptor inhibitors, and some cytotoxic agents. Immune-related adverse reactions like immune reconstitution inflammatory syndrome may occur when using this medication, so caution is necessary. Severe skin reactions may occur, and if painful rashes or severe skin abnormalities develop, the medication should be discontinued immediately, and medical consultation is advised. Due to significant interactions with other medications, it is essential to check the medications being taken before and after administration and inform healthcare professionals. The safety of this medication during pregnancy has not been adequately established, so pregnant women should use it cautiously after consulting a specialist. Breastfeeding women are advised to discontinue breastfeeding as this medication may be transmitted through breast milk and could harm the infant. This medication is not recommended for use in pediatric patients under 18 years of age as its safety and efficacy have not been established. Caution is advised in the elderly due to decreased liver, kidney, and heart function and higher frequency of medication usage. No dose adjustment is necessary for patients with mild renal or hepatic impairment, however, there is insufficient research on severely ill patients. In cases of overdose, no specific antidote exists, so symptoms should be monitored, and appropriate supportive treatment should be administered. This medication should be stored in a tightly sealed container to avoid exposure to air or moisture, and it should be kept at room temperature between 1 to 30 degrees Celsius to maintain its efficacy.

Side effects

Immune reconstitution syndrome, nausea, headache, fatigue, diarrhea, abdominal pain, dizziness, rash, strange dreams, insomnia, drowsiness, toxic epidermal necrolysis (TEN), severe skin reactions, painful rashes involving mucous membranes, progressive severe rash, depression, suicide/self-harm, elevated serum ALT, elevated serum AST

Not everyone experiences these, and they can vary from person to person.

Storage

This medication is sensitive to air and moisture, so it should be stored in a tightly sealed container. It is recommended to maintain storage temperatures between 1 to 30 degrees Celsius. Proper storage helps to maintain the medication's efficacy.

Appearance and packaging

Appearance

White oval tablets engraved with 'MSD logo' and '700' on one side

Package unit

30 tablets/bottle

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.