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Thalitero (50mg / 100mg) - Thalidomide Capsules

Thalitero (50mg / 100mg) - Thalidomide Capsules

Thalitero contains Thalidomide, an immunomodulatory and anti-angiogenic drug used primarily in the treatment of multiple myeloma, erythema nodosum leprosum (ENL), and various cancers. It acts by modulating the immune response and inhibiting tumor-related blood vessel formation.

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Description Product Details
General Information:
Generic Name: Thalidomide
Brand Name: Thalitero
Packing: Blister strips in cartons
Strengths Available: 50 mg and 100 mg capsules
Manufacturer: Typically oncology-focused pharmaceutical companies
Form: Oral hard gelatin capsules
Category: Immunomodulatory agent; Anti-angiogenic agent; Antineoplastic agent
Product Introduction:
Thalitero is a formulation of Thalidomide, a powerful drug with anti-inflammatory, immunomodulatory, and anti-angiogenic properties. Originally developed as a sedative, it was later repurposed for the treatment of multiple myeloma and dermatologic manifestations of leprosy, and is now being explored in various solid and hematological malignancies.
Uses (Indications):
Thalitero (Thalidomide) is used for:
  1. Multiple Myeloma – especially in combination with dexamethasone or chemotherapy
  2. Erythema Nodosum Leprosum (ENL) – acute and chronic treatment
  3. Myelodysplastic Syndromes (MDS) – off-label for anemia
  4. Prostate Cancer – investigational use
  5. Renal Cell Carcinoma (RCC) – in combination regimens
  6. Kaposi Sarcoma and glioblastoma – in experimental protocols
  7. Cutaneous lupus erythematosus and Behçet’s disease – under special circumstances
Storage Instructions:
  1. Store at 20–25°C (68–77°F)
  2. Keep in original packaging to protect from moisture
  3. Protect from light and heat
  4. Keep away from children and pregnant women
  5. Comply with special dispensing and storage precautions due to teratogenic risk
How It Works (Mechanism of Action):
Thalidomide exhibits a multi-modal mechanism of action:
  1. Immunomodulatory: Inhibits production of TNF-alpha and other pro-inflammatory cytokines
  2. Anti-angiogenic: Inhibits vascular endothelial growth factor (VEGF), reducing blood supply to tumors
  3. Antiproliferative: Suppresses abnormal cell growth in hematological malignancies
  4. Enhances T-cell and NK-cell mediated immunity
  5. In multiple myeloma, it disrupts the tumor microenvironment, affecting plasma cell survival
Side Effects:
Common Side Effects:
  1. Fatigue
  2. Constipation
  3. Rash
  4. Dizziness or somnolence
  5. Peripheral neuropathy
  6. Edema
  7. Orthostatic hypotension
Serious Side Effects:
  1. Teratogenicity – causes severe birth defects (strict pregnancy prevention program required)
  2. Peripheral neuropathy – irreversible if not detected early
  3. Deep vein thrombosis (DVT) and pulmonary embolism (PE)
  4. Severe skin reactions – including Stevens-Johnson syndrome
  5. Hepatotoxicity and neutropenia
  6. Bradycardia and seizures (in predisposed individuals)
Dosage (Typical Recommended Dose):
  1. Multiple Myeloma:
    1. 100 to 200 mg once daily at bedtime, often with dexamethasone
    2. Titrate based on tolerance and response
  2. ENL (Leprosy-related):
    1. 100–300 mg/day in divided doses
    2. Maintenance doses are often reduced over time
  3. Elderly or renally impaired: May require dose adjustments
  4. Duration of treatment is based on clinical response and tolerability
Method of Administration:
  1. Administer orally with water, ideally at bedtime to reduce sedative side effects
  2. Do not chew or open the capsules
  3. Capsules must be swallowed whole
  4. Take at the same time each day for consistency
  5. Adherence to contraceptive guidelines is mandatory for women of childbearing potential
Precautions:
  1. Strictly contraindicated in pregnancy – use under REMS or similar program
  2. Two reliable methods of contraception for women of childbearing potential
  3. Men must use condoms during treatment and for 4 weeks after the last dose if partner is pregnant or of childbearing potential
  4. Monitor for peripheral neuropathy with regular neurologic exams
  5. Baseline and periodic CBC, LFTs, and renal function monitoring
  6. Prophylactic anticoagulation may be recommended in high-risk myeloma patients
  7. Avoid alcohol and sedatives due to additive CNS depression
Drug Interactions:
  1. Sedatives, alcohol, and CNS depressants – may worsen drowsiness
  2. Hormonal contraceptives – effectiveness may be reduced
  3. Dexamethasone and chemotherapy agents – increased risk of thromboembolism
  4. Neuropathic drugs – may worsen neurotoxicity
  5. Live vaccines – should be avoided during treatment
Allergies (Warnings for Allergic Reactions):
  1. Hypersensitivity to Thalidomide or capsule ingredients
  2. Signs include swelling, rash, itching, shortness of breath
  3. Severe cutaneous reactions such as DRESS, SJS, or TEN necessitate immediate discontinuation
  4. Carry out allergy assessment before initiating therapy
Overdose Information:
  1. Overdose may lead to severe sedation, hypotension, bradycardia, or seizures
  2. Supportive care is the mainstay of treatment
  3. Activated charcoal may be considered if within 1–2 hours of ingestion
  4. No specific antidote is available
  5. Monitoring in a critical care setting may be necessary for severe toxicity
Missed Dose Instructions:
  1. If a dose is missed, take it as soon as remembered
  2. If it's almost time for the next dose, skip the missed dose
  3. Do not double the dose to make up for a missed one
  4. Maintain regular dose schedule to ensure consistent therapeutic effect
Additional Notes:
  1. Patients must be enrolled in a Pregnancy Prevention Program
  2. Monthly pregnancy tests are mandatory for women of reproductive potential
  3. Prescribers and pharmacists must be certified in the safety monitoring program (REMS)
  4. Patients must be counseled on thrombosis risk and signs of neuropathy
  5. Use with caution in elderly, bedridden, or dehydrated patients
  6. Regular neurologic and hematologic assessments are essential during therapy

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