Adult Dosing

HIV-1 infection

• Treatment-naive or treatment-experienced integrase strand transfer inhibitor (INSTI)-naive patients: 50 mg PO qDaily
• Treatment-naive or treatment-experienced INSTI-naive when coadministered with the following potent UGT1A/CYP3A inducers: efavirenz, fosamprenavir/ritonavir, tipranavir/ritonavir, or rifampin: 50 mg PO BID
• INSTI-experienced with certain INSTI-associated resistance substitutions or clinically suspected INSTI resistance: 50 mg PO BID

Pediatric Dosing

HIV-1 infection

• Treatment-naive or treatment-experienced INSTI naive (pediatric patients aged 12 years and older and weighing at least 40 kg): 50 mg PO qDaily
• If efavirenz, fosamprenavir/ritonavir, tipranavir/ritonavir, or rifampin are coadministered, the recommended dose is 50 mg PO bid
• Safety and efficacy have not been established in pediatric patients < 12 years or weighing < 40 kg, or in pediatric patients who are INSTI-experienced with documented or clinically suspected resistance to other INSTIs (raltegravir, elvitegravir)

[Outline]

• Adult Dosing
• Pediatric Dosing

• In combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and children aged 12 years and older and weighing at least 40 kg

• Hypersensitivity to any of the ingredients of the product
• Coadministration with dofetilide

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined; use with caution

Hepatic Dose Adjustment :

• Mild/Moderate hepatic impairment: No dosage adjustments
• Severe hepatic impairment: Dose adjustments not defined; use with caution

• Hypersensitivity reactions characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury have been reported with use of dolutegravir. Discontinue therapy and other suspect agents immediately if signs or symptoms of hypersensitivity reactions develop (including, but not limited to, severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters or peeling of the skin, oral blisters or lesions, conjunctivitis, facial edema, hepatitis, eosinophilia, angioedema, difficulty breathing)
• Delay in discontinuing treatment with dolutegravir or other suspect agents after the onset of hypersensitivity may result in a life-threatening reaction
• Hepatitis B or C patients may be at increased risk for worsening or development of transaminase elevations. Appropriate laboratory testing prior to initiating therapy and monitoring for hepatotoxicity during therapy with dolutegravir are recommended in such patients
• Closely monitor liver aminotransferases, and initiate appropriate therapy. Use appropriate laboratory testing prior to initiating therapy and monitoring for hepatotoxicity during therapy are recommended.
• Patients receiving antiretroviral therapy have experienced redistribution/accumulation of body fat, including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and “cushingoid appearance”
• Patients treated with combination antiretroviral therapy including dolutegravir have reported immune reconstitution syndrome. During the initial phase of treatment, patients whose immune systems respond may develop an inflammatory response to indolent or residual opportunistic infections (such as mycobacterium avium infection, cytomegalovirus, pneumocystis jirovecii pneumonia [PCP], or tuberculosis), may necessitate further evaluation and treatment
• Autoimmune disorders such as graves’ disease, polymyositis, and guillain-barré syndrome have also been reported to occur in the setting of immune reconstitution

Tivicay interacts with :

	Antacids
	Aptivus
	Bactrim
	Calcium supplements
	Carafate
	Dofetilide
	Efavirenz
	Etravirine
	Intelence
	Iron
	Magnesium supplements
	Rifadin
	Rifampin
	Rimactane
	Septra
	St. John's wort
	Sucralfate
	Sustiva
	Tikosyn
	Tipranavir

Pregnancy Category:B

Breastfeeding: The Centers for Disease Control and Prevention recommend that HIV-1-infected mothers do not breastfeed their infants to avoid risking postnatal transmission of HIV-1 infection. Because of both the potential for HIV transmission and the potential for adverse reactions in nursing infants, mothers should be instructed not to breastfeed if they are receiving dolutegravir.

• PSYCHIATRY: Insomnia, abnormal dreams
• CNS: Dizziness, headache, vertigo, fatigue
• MUSC: Myositis
• GU: Renal impairment
• GI: Abdominal pain, abdominal discomfort, flatulence, upper abdominal pain, vomiting, nausea, diarrhea
• DERM: Rash, pruritus
• HYPERSENSITIVITY: Hypersensitivity reactions

• Integrase strand transfer inhibitor (INSTI); inhibits viral replication by inhibiting HIV-1 integrase
• Metabolized in liver primarily by glucoronidation by the enzyme UDP-glucuronosy transferase (UGT) 1A1;CYP450: None
• Renally excreted 31% (< 1% unchanged)
• Half-life: 14 hrs

US Trade Name(s)

• Tivicay

US Availability

Tivicay

• TABS: 50 mg

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Antimicrobials

Antiviral (HIV) Agents

Integrase Inhibitors