vor-IN-o-stat

Therapeutic Classification: antineoplastics

Pharmacologic Classification: enzyme inhibitors

• Treatment of skin manifestations cutaneous T-cell lymphoma (CTCL) that has not responded to two systemic therapies.

• Acts as a histone deacetylase inhibitor which decreases gene transcription resulting in cell cycle arrest.

• Decreased progression of CTCL.

Absorption: Well absorbed following oral administration.

Distribution: Crosses the placenta.

Metabolism/Excretion: Mostly metabolized, <1% excreted unchanged in urine.

Half-life: 2 hr.

(blood levels)

Contraindicated in:

• Severe hepatic impairment
• OB: Pregnancy (may cause fetal harm)
• Lactation: Lactation.

Use Cautiously in:

• Renal impairment
• Mild or moderate hepatic impairment
• Pre-existing nausea, vomiting, diarrhea (treat symptomatically before initiating therapy)
• Rep: Women of reproductive potential and men with female partners of reproductive potential
• Pedi: Safety not established
• Geri: Older adults may be more sensitive to drug effects.

CV: deep vein thrombosis, QT interval prolongation.

Derm: alopecia, itching.

Endo: hyperglycemia.

GI: anorexia, constipation, diarrhea, dry mouth, nausea, vomiting.

GU: ↓fertility (females), proteinuria.

Hemat: anemia, thrombocytopenia.

Metab: weight loss.

MS: muscle spasms.

Neuro: dysgeusia, dizziness, headache.

Resp: PULMONARY EMBOLISM, cough.

Misc: chills, fever.

Drug-Drug:

• ↑risk of thrombocytopenia and GI bleeding with valproic acid.
• May ↑ risk of bleeding with warfarin.

• PO (Adults): 400 mg once daily; if intolerance occurs dose may be ↓ to 300 mg once daily or 300 mg once daily for 5 consecutive days/wk.

• Capsules: 100 mg;

• Monitor ECG prior to and periodically during therapy.
• Assess for nausea, vomiting, and diarrhea during therapy. Administer anti-emetic and antidiarrheal medications as needed. Maintain fluid and electrolyte balances to prevent adverse effects.

• Verify a negative pregnancy test within 7 days of starting therapy.
  • Monitor CBC and blood chemistry tests, including electrolytes (potassium, magnesium, calcium), glucose, and serum creatinine, every 2 wk during first 2 mo of therapy and monthly thereafter. Correct hypokalemia and hypomagnesemia before initiating therapy.
  • May cause thrombocytopenia and anemia requiring dose reduction or discontinuation.
  • May cause hyperglycemia requiring diet or insulin modification.
  • May cause proteinuria.

• PO: Administer once daily with food. Swallow capsules whole; do not open, crush, or chew.

• Instruct patient to take vorinostat as directed. Take missed doses as soon as remembered. If almost time for next dose, skip dose and take next dose at regular time; do not double doses. Advise patient to read Patient Information before starting therapy and with each Rx refill in case of changes.
• Advise patient to drink at least 2 L of fluid/day to prevent dehydration and to report vomiting or diarrhea to health care professional promptly.
• Instruct patient to notify health care professional immediately if signs of deep vein thrombosis (sudden swelling in leg, pain or tenderness in leg (may only be felt when standing or walking), increased warmth in the area of swelling, skin redness or change in skin color) or pulmonary embolus (sudden sharp chest pain, shortness or breath, cough with bloody secretions, sweating, rapid pulse, fainting, feeling anxious) occur. Also notify health care professional if unusual bleeding or bruising, or unusual tiredness occur.
• Advise diabetic patients to monitor blood glucose frequently as directed and notify health care professional if blood sugar is higher than normal.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken, and to consult health care professional before taking any new medications or herbal products.
• May cause dizziness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
• Rep: May have teratogenic effects. Advise females of reproductive potential to use effective contraception during and for at least 6 mo after last dose and to avoid breastfeeding during and for at least 1 wk after last dose. Advise males with female partners of reproductive potential to use effective contraception during and for at least 3 mo after last dose. May impair female fertility. Advise patient to notify health care professional immediately if pregnancy is suspected.

• Improvement in or decreased progression of CTCL.

Zolinza

• Risk for injury (Adverse Reactions).
• Deficient knowledge, Relate med (Patient/Family Teaching).

NDC Code^*

• 0006- Merck Sharp and Dohme Corp.
  • 0006-0568- ZOLINZA
    • 0006-0568-40- 120 CAPSULE in 1 BOTTLE (0006-0568-40)