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Thalix 100mg (Thalidomide)

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THALIX 100MG

Description

Thalidomide is generic form of brand name Thalix.

Thalix 100mg is classified as immunosuppressive and anti-angiogenic activity. It inhibits release of tumor necrosis factor-alpha from monocytes and modulates another cytokine action. 

Thalix 100mg is a prescription drug which is used under supervision of medical oncologist.

Indication

Thalix 100mg is indicated for the treatment in combination with dexamethasone of patients with newly diagnosed multiple myeloma and been investigation for indication in various cancer condition like renal cell carcinoma, glioblastoma multiforme and Waldenström’s macroglobulinemia

Thalix 100mg is also indicated for the treatment of skin lesions along with leprosy

Mechanism of action

Thalidomide mechanism of action carried out in various way; it can

  • Help the immune system physical assault and demolish cancer cells
  • Kill or blocks the growth of cancer cells
  • Affect the chemical messages that cancer cells need to survive
  • Stop the production of new blood vessels which cancer cells require to grow and spread.

ADME Properties

Absorption: Duration to high plasma concentration is 2.9 to 5.7 hours

Distribution: plasma protein binding is 55% and 66% for the (+) R and (-) S enantiomers, respectively

Metabolism: metabolized hepatically by enzymes of the cytochrome P450 enzyme system.

Elimination: excreted in the urine as unchanged drug is less than 0.7% of the dose.

Half-life of thalidomide is 5 to 7 hours.

Dosage and administration

The Thalix dosage recommendation of following condition as follows

Multiple Myeloma

The prescribed dose is 200mg PO qHS in 28-day cycles

Administer 40 mg of dexamethasone on days 1-4,9-12,17-20 of 28 days.

Erythema Nodosum leprosum

The starting prescribed dose is 100-300 mg PO qHS.

If more severe reaction then may start at 400mg. Extend until active symptoms diminish, at least 2 weeks then titrate down by 50 mg increment q 2-4 weeks.

Side effects

Thalix 100mg observes following side effects as follows

  • Asthenia
  • Xerostomia
  • Flatulence
  • Neck rigidity
  • Teratogenicity
  • Somnolence
  • Leukopenia
  • Increased bilirubin
  • Venous and arterial thromboembolism
  • Increased Mortality
  • Drowsiness and somnolence
  • Peripheral neuropathy
  • Dizziness and orthostatic hypotension
  • Neutropenia
  • Thrombocytopenia
  • Increased HIV viral load
  • Bradycardia
  • Seizures
  • Tumor Lysis
  • Hypersensitivity

Drug interaction

Interaction of Thalix 100mg with opioids, antihistamines, antipsychotics, anti-anxiety agents, other CNS depressants may lead to additive sedative effect.

Concomitant use of Thalix 100mg with cardiovascular medication will cause an additive bradycardic effect and should be used with caution.

Concomitant use with bortezomib, amiodarone, cisplatin, docetaxel, paclitaxel, vincristine etc will cause peripheral neuropathy and should be used with caution.

Unknown condition when concomitant use of hormonal contraceptives further increases the risk of thromboembolism with Thalix

Contraindication

Hypersentivity

Pregnancy - the drug cause risk to fetal

Precautions

For women of childbearing probably should use contraception 4 weeks before you can start Thalix. The manufacturer needed you to take a pregnancy test every month before you initiate a new prescription of thalidomide. This is to confirm that you or your significant other is not pregnant. Consult with your doctor when you may safely become pregnant or conceive a child after treatment.

Starting before Thalix treatment, make sure to inform doctor about any other medications you are taking (containing prescription, over-the-counter, vitamins, herbal remedies, etc.).   Avoid taking aspirin, or products including aspirin until the doctor especially permits this.

Do not administer drugs which may cause drowsiness without first consulting your health care provider.  Also avoid alcohol.

For both men and women use contraceptives, and do not conceive a child (get pregnant) while taking Thalix. serious, life-threatening birth defects may have reported with even one 50 mg dose.  Methods of contraception has two types, such as latex condoms and spermicides, are required. 

Avoid breast feed while taking this Thalix therapy.

Pregnancy

Pregnancy category X

Thalix should not administer to a pregnant woman or a woman who aims to become pregnant.

Thalix may cause risk to fetal when administer to a pregnant woman. 

If a woman becomes pregnant during Thalix therapy, the drug must be discontinued immediately, and the woman given correct counselling.

Lactation

There has no data available for the presence of Thalix in human milk and effects of drug on breastfed infants.

Avoid breastfeeding during treatment with Thalix 100mg

Storage

Store at 200C – 250C

Protect the drug from light

Missed dose

If dose is missed by patient, then take the dose immediately before next dose duration. Next dose time reaches then left off the missed dose and continues regular schedule. Avoid have double dose at same time. Must consult the doctor for further information.

  • Trade name Thalix 100mg
  • Substance Thalidomide
  • Manufacturer Fresenius Kabi India Pvt Ltd
  • Packaging 10 capsules
  • Country of origin India
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