Dosing & Uses
Dosage Forms & Strengths
Cutaneous T-cell Lymphoma
Indicated for treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma who have progressive, persistent, or recurrent disease during or following 2 systemic therapies
400 mg PO qDay
May reduce to 300 mg qDay, and then to 300 mg qDay for 5 days/wk if intolerant
Monitor: CBC, electrolytes, serum glucose and creatinine q2week during first 2 months and monthly thereafter
- Mild/moderate (Child-Pugh A or B): Use with caution
- Severe (Child-Pugh C): Contraindicated
Multiple Myeloma (Orphan)
Orphan designation for treatment of multiple myeloma
- Merck Research Laboratories; Merck & Co Inc; PO Box 2000, RY 33-212; Rahway, NJ 07065-0900
Orphan designation for treatment of advanced melanoma (stages IIb, IIc, III, and IV)
- Qameleon Therapeutics; Moslaan 32, 1433 WJ; Kudelstaart, Netherlands
Safety and efficacy not established
Serious - Use Alternative
Significant - Monitor Closely
Weight loss (20.9%)
Muscle spasms (19.8%)
Dry mouth (16%)
Increase serum Cr (16%)
Peripheral edema (12.8%)
Upper respiratory infection (10.5%)
Prolonged QT interval (3.5-6%)
Pulmonary embolism (4.7%)
Severe hepatic Impairment
Congenital long QT syndrome, drugs/conditions that prolong QT interval; correct hypokalemia or hypomagnesemia before commencing treatment
History of thromboembolic disease; potential for DVT/PE
Potential for hyperglycemia; caution in diabetes
Dose related anemia and thrombocytopenia may occur; modify dose or discontinue if reduction in platelets or Hgb
Concomitant valproic acid
May cause dizziness or fatigue
Concomitant coumarin-derived anticoagulants
Nausea, vomiting, or diarrhea
Drink at least 2 L of fluids daily
Pregnancy & Lactation
Pregnancy Category: D
Lactation: not known whether excreted in breast milk, do not nurse
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Mechanism of Action
Histone deacetylase inhibitor for enzymes HDAC1, HDAC2, HDAC3, and HDAC6, which in turn alters chromatin structure and transcription factor activation; as a result, cell growth is terminated and apoptosis occurs
Peak plasma time: 4 hr
Peak plasma concentration (400 mg dose): 1.2±0.62 umol/L
Fasted state has quicker peak time, but lower AUC and peak concentration
Taken with a high fat meal increases extent of absorption by 33%
Protein Bound: 71%
Half-Life, Terminal: 2 hr
Excretion: Urine 52%
Take with food
Drink at least 2 L of fluids daily
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.
|1||This drug is available at the lowest co-pay. Most commonly, these are generic drugs.|
|2||This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.|
|3||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.|
|4||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|5||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|6||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|NC||NOT COVERED – Drugs that are not covered by the plan.|
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.