DELSTRIGO is indicated for the treatment of adults, and adolescents aged 12 years and older weighing at least 35 kg infected with HIV-1 without past or present evidence of resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, lamivudine or tenofovir (see sections 4.4 and 5.1).
1. What DELSTRIGO is and what it is used for.
2. What you need to know before you take/use DELSTRIGO.
Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Co-administration with medicinal products that are strong cytochrome P450 (CYP)3A enzyme inducers is contraindicated as significant decreases in doravirine plasma concentrations are expected to occur, which may decrease the effectiveness of DELSTRIGO (see sections 4.4 and 4.5). These medicinal products include, but are not limited to the following:
- carbamazepine, oxcarbazepine, phenobarbitone, phenytoin
- rifampicin, rifapentine and any other tuberculosis medicines which are strong CYP3A enzyme inducers.
- St. John’s wort (Hypericum perforatum)
- mitotane
- enzalutamide
- lumacaftor
- moderate and severe renal impairment (CrCL < 50 mL/minute).
Special warnings and precautions for use
While effective viral suppression with antiretroviral therapy has been proven to substantially reduce the risk of sexual transmission of HIV-1, a residual risk cannot be excluded. Precautions to prevent transmission should be taken in accordance with national guidelines.
3. How to take/use DELSTRIGO.
Therapy should be initiated by a medical practitioner experienced in the management of HIV-infection. The recommended dose of DELSTRIGO is one 100/300/245 mg tablet taken orally once daily with or without food.
Missed dose
If the patient misses a dose of DELSTRIGO within 12 hours of the time it is usually taken, the patient should take DELSTRIGO as soon as possible and resume the normal dosing schedule. If a patient misses a dose of DELSTRIGO by more than 12 hours, the patient should not take the missed dose and instead take the next dose at the regularly scheduled time. The patient should not take 2 doses at one time.
4. Possible side effects.
Undesirable effects
The most frequently reported adverse reactions considered possibly or probably related to doravirine were nausea (4 %) and headache (3 %).
Tabulated summary of adverse reactions
The adverse reactions with suspected (at least possible) relationship to treatment are listed below by body system organ class and frequency. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000) or very rare (< 1/10 000).
5. How to store DELSTRIGO.
Special precautions for storage
Store at or below 30 °C. Store in the original bottle and keep the bottle tightly closed in order to protect from moisture. Do not remove the desiccant.