Usual Adult Dose for Leprosy - Erythema Nodosum Leprosum

• Episode of Cutaneous Erythema Nodosum Leprosum (ENL): Initiate treatment at 100 to 300 mg orally once a day with water, preferably at bedtime and at least 1 hour after the evening meal; start at the lower end of the dose range for patients weighing less than 50 kg.

• Severe Cutaneous ENL Reaction, or Patients Who Previously Required Higher Doses: Initiate treatment at higher doses up to 400 mg/day orally once a day at bedtime or in divided doses with water, at least 1 hour after meals.

• Duration of Therapy: Usually continue until signs and symptoms of active reaction have subsided (usually at least 2 weeks), then may taper off medication in 50 mg decrements every 2 to 4 weeks.

Comments: May concomitantly start corticosteroids in patients with moderate to severe neuritis associated with a severe ENL reaction; can taper and discontinue steroid use when the neuritis has ameliorated.

Uses:

• Acute monotherapy treatment of the cutaneous manifestations of moderate to severe ENL (except in the presence of moderate to severe neuritis).
• As maintenance therapy for the prevention and suppression of the cutaneous manifestations of ENL recurrence.

Usual Adult Dose for Multiple Myeloma

200 mg orally once a day with water, preferably at bedtime and at least 1 hour after the evening meal.

• Duration of Therapy: 28-day treatment cycles

Comments: Consult the manufacturer product information for dexamethasone dosing recommendations.

Use: Treatment of newly diagnosed multiple myeloma (MM) in combination with dexamethasone.

Usual Pediatric Dose for Leprosy - Erythema Nodosum Leprosum

Age 12 Years and Older:

• Episode of Cutaneous Erythema Nodosum Leprosum (ENL): Initiate treatment at 100 to 300 mg orally once a day with water, preferably at bedtime and at least 1 hour after the evening meal; start at the lower end of the dose range for patients weighing less than 50 kg.

• Severe Cutaneous ENL Reaction, or Patients Who Previously Required Higher Doses: Initiate treatment at higher doses up to 400 mg/day orally once a day at bedtime or in divided doses with water, at least 1 hour after meals.

• Duration of Therapy: Usually continue until signs and symptoms of active reaction have subsided (usually at least 2 weeks), then may taper off medication in 50 mg decrements every 2 to 4 weeks.

Comments: May concomitantly start corticosteroids in patients with moderate to severe neuritis associated with a severe ENL reaction; can taper and discontinue steroid use when the neuritis has ameliorated.

Uses:

• Acute monotherapy treatment of the cutaneous manifestations of moderate to severe ENL (except in the presence of moderate to severe neuritis).
• As maintenance therapy for the prevention and suppression of the cutaneous manifestations of ENL recurrence.

Usual Pediatric Dose for Multiple Myeloma

Age 12 Years and Older:
200 mg orally once a day with water, preferably at bedtime and at least 1 hour after the evening meal.

• Duration of Therapy: 28-day treatment cycles

Comments: Consult the manufacturer product information for dexamethasone dosing recommendations.

Use: Treatment of newly diagnosed multiple myeloma (MM) in combination with dexamethasone.

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

Data not available.

Dose Adjustments

Multiple Myeloma (MM):

• Management of Adverse Reactions (e.g., constipation, somnolence, peripheral neuropathy): Consider either temporary treatment discontinuation or continuing treatment at a lower dose; with the abatement of these reactions, restart treatment at a lower dose or at the previous dose based on clinical judgment.

Erythema Nodosum Leprosum (ENL):

• Patients with Documented History of Requiring Prolonged Maintenance Treatment to Prevent Recurrence OR Who Flare During Tapering: Maintain minimum dose necessary to control cutaneous ENL reaction; attempt tapering off medication every 3 to 6 months, in 50 mg decrements every 2 to 4 weeks.

Precautions

US REMS: The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for this drug. It includes elements to assure safe use and an implementation system. For additional information: www.fda.gov/REMS or www.celgeneriskmanagement.com.

US BOXED WARNING:

• EMBRYO-FETAL TOXICITY: If this drug is used during pregnancy, it can cause severe birth defects or embryo-fetal death. This drug should never be used by females who are pregnant or who could become pregnant. Even a single dose (1 capsule, regardless of strength) can cause severe birth defects if taken by a pregnant woman.
• VENOUS THROMBOEMBOLISM: The use of this drug in multiple myeloma results in an increased risk of venous thromboembolism, such as deep venous thrombosis (DVT) and pulmonary embolism (PE). The risk increases significantly when this drug is used in combination with standard chemotherapeutic agents including dexamethasone. Advise patients to seek medical care if they develop symptoms such as shortness of breath, chest pain, or arm/leg swelling. Consider thromboprophylaxis based on an assessment of each individual patient's underlying risk factors.

Safety and efficacy have not been established in patients younger than 12 years.

Consult WARNINGS section for additional precautions.

Dialysis

No adjustment recommended.

Other Comments

Administration Advice:

• Instruct patients not to open or crush drug capsules.
• To reduce the risk of capsule deformation or breakage, advise patients to press only on one end of a capsule to remove it from the blister pack.

Storage Requirements:

• Store at 20 to 25 degrees Celsius (68 to 77 degrees Fahrenheit); excursions permitted to 15 to 30 degrees C/59 to 86 degrees F.
• Protect from light.
• Keep in the original package.

General:

• Drug prescribing to females of reproductive potential is contingent upon initial and continued negative results of pregnancy testing.
• Overdosage: There is no specific antidote; monitor vital signs and administer appropriate supportive care if an event occurs.

Monitoring:

• CARDIOVASCULAR: Atrioventricular block, bradycardia/syncope, underlying cardiopulmonary disease, thromboembolism
• DERMATOLOGIC: Rash/skin reactions
• ENDOCRINE: Thyroid activity
• HEMATOLOGIC: Blood counts (white blood cell count, differential, platelets), signs/symptoms of neutropenia, thrombocytopenia, and bleeding
• HEPATIC: Liver function
• IMMUNOLOGIC: Severe infections (e.g., sepsis, septic shock), viral reactivation
• NERVOUS SYSTEM: Dizziness/orthostatic hypotension, drowsiness, somnolence, sedation, peripheral neuropathy, clinical changes that could precipitate acute seizure activity
• ONCOLOGIC: Standard cancer screening
• OTHER: Patients at risk of tumor lysis syndrome (e.g., patients with high tumor burden prior to treatment)

Patient Advice:

• This drug may cause side effects including drowsiness and blurred vision; do not drink alcohol while taking this drug and avoid potentially dangerous activities such as driving and operating machinery until you know how this drug affects you.