dividuals of childbearing potential to use effectivecontraception. (2.1, 5.4, 8.1, 8.3)
• Lactic acidosis and severe hepatomegaly with steatosis, including fatalcases, have been reported with the use of nucleoside analogues. (5.5)
• Immune reconstitution syndrome has been reported in patients treatedwith combination antiretroviral therapy. (5.7)
ADVERSE REACTIONS
The most common adverse reactions (all grades) observed in ≥2% (in thosereceiving DOVATO) were headache, diarrhea, nausea, insomnia, and fatigue.(6.1)
To report SUSPECTED ADVERSE REACTIONS, contact ViiVHealthcare at 1-877-844-8872 or FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch.
DRUG INTERACTIONS
• DOVATO is a complete regimen for the treatment of HIV-1 infection;therefore, coadministration with other antiretroviral drugs for the treatmentof HIV-1 infection is not recommended. (7.1)
• Refer to the full prescribing information for important drug interactionswith DOVATO. (4, 5.6, 7)
USE IN SPECIFIC POPULATIONS
• Pregnancy: Avoid use of DOVATO at the time of conception through thefirst trimester due to the risk of neural tube defects. (2.1, 5.4, 8.1)
• Lactation: Breastfeeding is not recommended due to the potential forHIV-1 transmission. (8.2)
• Females and males of reproductive potential: Pregnancy testing andcontraception are recommended in individuals of childbearing potential.(8.3)
• Renal Impairment: DOVATO is not recommended in patients with
creatinine clearance less than 50 mL/min. (8.6)
• Hepatic Impairment: DOVATO is not recommended in patients withsevere hepatic impairment (Child-Pugh Score C). (8.7)
See 17 for PATIENT COUNSELING INFORMATION and Patient
Information.
Revised: 04/2019
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FULL PRESCRIBING INFORMATION: CONTENTS*WARNING: PATIENTS CO-INFECTED WITH HEPATITIS BVIRUS (HBV) AND HUMAN IMMUNODEFICIENCY VIRUS (HIV-
1): EMERGENCE OF LAMIVUDINE-RESISTANT HBV ANDEXACERBATIONS OF HBV
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Testing Prior to or When Initiating Treatment withDOVATO
2.2 Recommended Dosage
2.3 Recommended Dosage with Certain Coadministered Drugs
2.4 Not Recommended in Patients with Renal Impairment
2.5 Not Recommended in Patients with Severe HepaticImpairment
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Patients Co-infected with HIV-1 and HBV: Emergence ofLamivudine-Resistant HBV and the Risk of PosttreatmentExacerbations of HBV
5.2 Hypersensitivity Reactions
5.3 Hepatotoxicity
5.4 Embryo-Fetal Toxicity
5.5 Lactic Acidosis and Severe Hepatomegaly with Steatosis
5.6 Risk of Adverse Reactions or Loss of Virologic Response
Due to Drug Interactions
5.7 Immune Reconstitution Syndrome
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
7.1 Coadministration with Other Antiretroviral Drugs
7.2 Potential for DOVATO to Affect Other Drugs
7.3 Potential for Other Drugs to Affect the Components ofDOVATO
7.4 Established and Other Potentially Significant DrugInteractions
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.3 Females and Males of Reproductive Potential
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
8.7 Hep |
