Adult Dosing

HIV-1 infection

• 300 mg PO bid or 600 mg PO qd

Pediatric Dosing

HIV-1 infection

• Child 3 mo: 8 mg/kg bid. Maximum 300 mg bid
• 14-21 kg: 150 mg PO bid; Max: 600 mg/day
• >21-<30 kg: 150 mg PO qam, 300 mg PO qpm; Max: 600 mg/day
• >30 kg: 300 mg PO bid; Max: 600 mg/day

Note:

• HLA-B*5701 allele screening recommended before starting therapy

[Outline]

• Adult Dosing
• Pediatric Dosing

• HIV-1 infection, in combination with other antiretroviral agents

• Hypersensitivity to any of the ingredients of the product
• Moderate or severe hepatic impairment

• HLA-B*5701 allele screening recommended before starting therapy
• Hypersensitivity reactions, typically with multi-organ involvement may occur, and are often serious, even fatal
• Patients who carry the HLA-B*5701 allele are at high risk for hypersensitivity reactions. Prior to initiating therapy with abacavir, screening for the HLA-B*5701 allele is recommended
• On evidence or suspicion of hypersensitivity reaction occur; discontinue abacavir (Ziagen) permanently
• Following a hypersensitivity reaction, never restart abacavir (Ziagen)
• Lactic acidosis risk, severe hepatomegally with steatosis, including fatal cases have been reported

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Mild hepatic impairment (Child-Pugh Score 5 to 6): 200 mg bid
• Moderate and Severe hepatic impairment: Therapy contraindicated

• Abacavir therapy may lead to serious and sometimes fatal hypersensitivity reactions. Suspend therapy on occurrence of such hypersensitivity reactions [US Black Box Warning]
• Patients who carry the HLA-B*5701 allele are at high risk for hypersensitivity reactions [US Black Box Warning]
• Lactic acidosis and severe hepatomegaly with steatosis have been reported with the use of abacavir. Suspend if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity [US Black Box Warning]
• Abacivir with other antiretroviral agents may develop immune reconstitution syndrome. Evaluate and treat if an inflammatory response to indolent or residual opportunistic infections occurs during initial phase of therapy
• Incidences of myocardial infarction and fat redistribution may occur. Use cautiously in patients with coronary heart disease

Cautions: Use cautiously in

• Mild hepatic impairment
• HLA-B*5701-positive patients
• Baseline viral load >100,000
• Long-term nucleoside treatment
• Female patients
• Obesity
• CHD
• Cardiac disease risk

Pregnancy Category:C

Breastfeeding: Safety Unknown, women with HIV infection should not breastfeed. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 28 December 2010). According to the manufacturer data, because of both the potential for HIV-1 transmission and the potential for serious adverse reactions in nursing infants, mothers should be instructed not to breastfeed if they are receiving therapy.

• CNS: Headache, insomnia, fatigue, depression, anxiety
• CV: Severe hypotension, myocardial infarction
• GI: Nausea, vomiting, anorexia, hepatomegaly (with steatosis), diarrhea, hepatic failure, lactic acidosis, pancreatitis, elevated liver transaminases
• DERM: Rashes, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme
• GU: Renal failure
• METABOLIC: Hypertriglyceridemia
• RESP: ARDS, respiratory failure, URI
• MISC: Hypersensitivity reactions, anaphylaxis, immune reconstitution syndrome, fever/chills, lipodystrophy, death

• Nucleoside reverse transcriptase inhibitor (antiretroviral); its active metabolite terminates viral DNA by inhibiting the activity of HIV-1 reverse transcriptase
• Mostly metabolized by liver; not significantly metabolized by CYP450
• Renally excreted: 82.2% (1.2% unchanged), feces 16%
• Half-life: 1.5 hrs (Mild hepatic impairment: 2.4 hrs)

US Trade Name(s)

• Ziagen

US Availability

abacavir (generic)

• TABS: 300 mg

Ziagen

• TABS: 300 mg
• SOLN: 20 mg/mL

Canadian Trade Name(s)

• Ziagen

Canadian Availability

Ziagen

• TABS: 300 mg
• SOLN: 20 mg/mL

UK Trade Name(s)

• Ziagen

UK Availability

Ziagen

• TABS: 300 mg
• SOLN: 20 mg/mL

Australian Trade Name(s)

• Ziagen

Australian Availability

Ziagen

• TABS: 300 mg
• SOLN: 20 mg/mL

[Outline]

Antimicrobials

Antiviral (HIV) Agents

NRTIs

Infectious Disease

Antiviral (HIV) Agents

NRTIs

Pricing data from www.DrugStore.com in U.S.A.

• Ziagen 300 MG TABS [Bottle] (VIIV HEALTHCARE)
  60 mg = $608.01
  120 mg = $1153.93
• Ziagen 20 MG/ML SOLN [Bottle] (VIIV HEALTHCARE)
  240 ml = $143.99
  720 ml = $419.97

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Drug Name: Ziagen 300 MG Oral Tablet

Ingredient(s): Abacavir

Imprint: GX;623

Color(s): Yellow

Shape: Oval

Size (mm): 18.00

Score: 2

Inactive Ingredient(s): colloidal silicon dioxide / magnesium stearate / cellulose, microcrystalline / sodium starch glycolate type a potato / hypromellose / polysorbate 80 / ferric oxide yellow / triacetin / titanium dioxide

Drug Label Author:
GlaxoSmithKline LLC

DEA Schedule:
Non-Scheduled

Drug Name: Ziagen 300 MG Oral Tablet

Ingredient(s): Abacavir

Imprint: GX;623

Color(s): Yellow

Shape: Oval

Size (mm): 18.00

Score: 2

Inactive Ingredient(s): colloidal silicon dioxide / magnesium stearate / cellulose, microcrystalline / sodium starch glycolate type a potato / hypromellose / polysorbate 80 / ferric oxide yellow / triacetin / titanium dioxide

Drug Label Author:
State of Florida DOH Central Pharmacy

DEA Schedule:
Non-Scheduled