Dolutegravir Sodium
Generic Name: dolutegravir sodium
Brand Names:
Tivicay
11 DESCRIPTION TIVICAY contains dolutegravir, as dolutegravir sodium, an HIV INSTI. The chemical name of dolutegravir sodium is sodium (4 R ,12a S )-9-{[(2,4-difluorophenyl)methyl]carbamoyl}-4-methyl-6,8-dioxo-3,4,6,8,12,12a-hexahydro-2 H -pyrido[1',2':4,5]pyrazino[2,1- b ][1,3]oxazin-7-olate. The empirical formula is C 20 H 18 F 2 N 3 NaO 5, and the molecular weight is 441.36 g/mol.
Overview
11 DESCRIPTION TIVICAY contains dolutegravir, as dolutegravir sodium, an HIV INSTI. The chemical name of dolutegravir sodium is sodium (4 R ,12a S )-9-{[(2,4-difluorophenyl)methyl]carbamoyl}-4-methyl-6,8-dioxo-3,4,6,8,12,12a-hexahydro-2 H -pyrido[1',2':4,5]pyrazino[2,1- b ][1,3]oxazin-7-olate. The empirical formula is C 20 H 18 F 2 N 3 NaO 5, and the molecular weight is 441.36 g/mol.
Uses
1 INDICATIONS AND USAGE TIVICAY and TIVICAY PD are indicated in combination with other antiretroviral agents for the treatment of HIV‑1 infection in adults (treatment-naïve or -experienced) and in pediatric patients (treatment-naïve or -experienced but integrase strand transfer inhibitor [INSTI]-naïve) aged at least 4 weeks and weighing at least 3 kg [see Microbiology ( 12.4 )].
Dosage
2 DOSAGE AND ADMINISTRATION May be taken without regard to food. ( 2.2 , 2.6) UGT = uridine diphosphate glucuronosyltransferase; CYP = cytochrome P450. a Rilpivirine dose is 25 mg once daily for those switching to dolutegravir plus rilpivirine. b Alternative combinations that do not include metabolic inducers should be considered where possible.
Side Effects
6 ADVERSE REACTIONS The following serious adverse drug reactions are discussed in other sections of the labeling: Hypersensitivity reactions [see Warnings and Precautions ( 5.1 )] . Hepatotoxicity [see Warnings and Precautions ( 5.2 )]. Immune Reconstitution Syndrome [see Warnings and Precautions ( 5.4 )] . The most common adverse reactions of moderate to severe intensity and incidence at least 2% (in those receiving TIVICAY in any one adult trial) are insomnia, fatigue, and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact ViiV Healthcare at 1-877-844-8872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Interactions
7 DRUG INTERACTIONS Refer to the full prescribing information for important drug interactions with TIVICAY or TIVICAY PD. ( 4 , 7 ) Drugs that are metabolic inducers may decrease the plasma concentrations of dolutegravir. ( 7.2 , 7.3 ) TIVICAY or TIVICAY PD should be taken 2 hours before or 6 hours after taking cation-containing antacids or laxatives, sucralfate, oral supplements containing iron or calcium, or buffered medications. When taken with food, TIVICAY and supplements containing calcium or iron can be taken at the same time. ( 7.3 ) 7.1 Effect of Dolutegravir on the Pharmacokinetics of Other Agents In vitro, dolutegravir inhibited the renal organic cation transporters, OCT2 (IC 50 = 1.93 microM) and multidrug and toxin extrusion transporter (MATE) 1 (IC 50 = 6.34 microM).
Warnings
5 WARNINGS AND PRECAUTIONS Hypersensitivity reactions characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury, have been reported. Discontinue TIVICAY or TIVICAY PD and other suspect agents immediately if signs or symptoms of hypersensitivity reactions develop, as a delay in stopping treatment may result in a life-threatening reaction. ( 5.1 ) Hepatotoxicity has been reported in patients receiving dolutegravir-containing regimens. Patients with underlying hepatitis B or C may be at increased risk for worsening or development of transaminase elevations. Monitoring for hepatotoxicity is recommended. ( 5.2 ) Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy. 4 CONTRAINDICATIONS TIVICAY and TIVICAY PD are contraindicated in patients: with previous hypersensitivity reaction to dolutegravir [see Warnings and Precautions ( 5.1 )]. receiving dofetilide due to the potential for increased dofetilide plasma concentrations and the risk for serious and/or life-threatening events [see Drug Interactions ( 7 )] .
Pregnancy
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to TIVICAY or TIVICAY PD during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING TIVICAY tablets, 50 mg, are yellow, round, film-coated, biconvex tablets debossed with “SV 572” on one side and “50” on the other side. Bottle of 30 tablets with child-resistant closure. NDC 60760-748-07 BOTTLES OF 7 Store TIVICAY tablets at 25°C (77°F); excursions permitted 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
Frequently Asked Questions
What is Dolutegravir Sodium used for?▼
1 INDICATIONS AND USAGE TIVICAY and TIVICAY PD are indicated in combination with other antiretroviral agents for the treatment of HIV‑1 infection in adults (treatment-naïve or -experienced) and in pediatric patients (treatment-naïve or -experienced but integrase strand transfer inhibitor [INSTI]-naïve) aged at least 4 weeks and weighing at least 3 kg [see Microbiology ( 12.4 )].
What are the side effects of Dolutegravir Sodium?▼
6 ADVERSE REACTIONS The following serious adverse drug reactions are discussed in other sections of the labeling: Hypersensitivity reactions [see Warnings and Precautions ( 5.1 )] . Hepatotoxicity [see Warnings and Precautions ( 5.2 )]. Immune Reconstitution Syndrome [see Warnings and Precautions ( 5.4 )] . The most common adverse reactions of moderate to severe intensity and incidence at least 2% (in those receiving TIVICAY in any one adult trial) are insomnia, fatigue, and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact ViiV Healthcare at 1-877-844-8872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Can I take Dolutegravir Sodium during pregnancy?▼
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to TIVICAY or TIVICAY PD during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263.
What are the important warnings for Dolutegravir Sodium?▼
5 WARNINGS AND PRECAUTIONS Hypersensitivity reactions characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury, have been reported. Discontinue TIVICAY or TIVICAY PD and other suspect agents immediately if signs or symptoms of hypersensitivity reactions develop, as a delay in stopping treatment may result in a life-threatening reaction. ( 5.1 ) Hepatotoxicity has been reported in patients receiving dolutegravir-containing regimens. Patients with underlying hepatitis B or C may be at increased risk for worsening or development of transaminase elevations. Monitoring for hepatotoxicity is recommended. ( 5.2 ) Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy. 4 CONTRAINDICATIONS TIVICAY and TIVICAY PD are contraindicated in patients: with previous hypersensitivity reaction to dolutegravir [see Warnings and Precautions ( 5.1 )]. receiving dofetilide due to the potential for increased dofetilide plasma concentrations and the risk for serious and/or life-threatening events [see Drug Interactions ( 7 )] .
Related Medications
Acer Negundo Pollen, Betula Nigra Pollen, Black Walnut, Carya Ovata Pollen, Fraxinus Americana Pollen, Platanus Occidentalis Pollen, Populus Deltoides Subsp. Monilifera Pollen, Quercus Rubra Pollen, Salix Nigra Pollen And Ulmus Americana Pollen
acer negundo pollen, betula nigra pollen, black walnut, carya ovata pollen, fraxinus americana pollen, platanus occidentalis pollen, populus deltoides subsp. monilifera pollen, quercus rubra pollen, salix nigra pollen and ulmus americana pollen
Dosage form: INJECTION, SOLUTION. Route: SUBCUTANEOUS. Active ingredients: ACER NEGUNDO POLLEN (.05 g/mL); BETULA NIGRA POLLEN (.05 g/mL); BLACK WALNUT (.05 g/mL); CARYA OVATA POLLEN (.05 g/mL); FRAXINUS AMERICANA POLLEN (.05 g/mL); PLATANUS OCCIDENTALIS POLLEN (.05 g/mL); POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN (.05 g/mL); QUERCUS RUBRA POLLEN (.05 g/mL); SALIX NIGRA POLLEN (.05 g/mL); ULMUS AMERICANA POLLEN (.05 g/mL). Category: BLA.
Aconitum Nap., Anacardium, Arg. Nit., Arsenicum Alb., Cypripedium, Gelsemium, Ignatia, Kali Carb., Lycopodium, Nat.mur., Phos., Sambucus Nig., Sepia, Staphysag., Stramonium, Tarentula Hispana, Theridion, Passiflora, Valeriana
aconitum nap., anacardium, arg. nit., arsenicum alb., cypripedium, gelsemium, ignatia, kali carb., lycopodium, nat.mur., phos., sambucus nig., sepia, staphysag., stramonium, tarentula hispana, theridion, passiflora, valeriana
OTC - PURPOSE SECTION Formulated for symptoms associated with performance anxiety such as apprehension, nausea, restlessness, trembling and over-sensitivity.
Xylometazoline Hydrochloride
xylometazoline hydrochloride
■ relieve your cold symptoms cold Rhinitis
Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.