DOMIDE CAPSULES 50MG [SIN16362P]

Product Info

DOMIDE CAPSULES 50MG

[SIN16362P]

【INDICATION】
Multiple Myeloma (MM):

• DOMIDE in combination with melphalan and prednisone is indicated for the treatment of patients with untreated multiple myeloma ≥65 years or ineligible for high dose chemotherapy.

• DOMIDE in combination with dexamethasone is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue, for the treatment of patients with untreated multiple myeloma.

【POSOLOGY AND METHOD OF ADMINISTRATION】

• Drugs prescribed to women of childbearing potential must be contingent upon initial and continued confirmed negative results of pregnancy testing.

• Thalidomide treatment must be initiated and monitored under the supervision of physicians with expertise in managing immunomodulatory or chemotherapeutic agents and a full understanding of the risks of thalidomide therapy and monitoring requirements.

• To reduce central nervous system effects (e.g. drowsiness, somnolence, sedation) during the day, Thalidomide is normally taken as a single dose in the evening. DOMIDE capsules should be taken at least one hour after food.

Multiple Myeloma (MM)

• The required total duration of treatment should be individually determined for each patient depending on tolerability and disease progression.

• Depending on tolerance and observed toxicity, lower maintenance doses can be used.

In Combination with Melphalan and Prednisone:

• The DOMIDE recommended oral dose is 200 mg per day. A maximum number of 12 cycles of 6 weeks (42 days) should be used.

• For patients > 75 years of age, the DOMIDE recommended starting dose is 100 mg per day.

In Combination with Dexamethasone:

• The DOMIDE recommended oral dose is 200 mg per day.

• For induction, 4 cycles of 4 weeks (28 days) of Thalidomide/dexamethasone is recommended.

• The dose of dexamethasone is 40 mg daily administered orally on days 1–4, 9–12, and 17–20 every 28 days.

• For elderly patients of poor performance, tolerability may be improved by starting the patient on 50 mg per day and increasing this dose to 200 mg per day over a 4 week period.

Dosage Adjustments During Treatment
Dosage delay or reduction, dependent upon grade of toxicity, may be necessary.
If less than 12 hours has elapsed since missing a dose, the patient can take the dose. If more than 12 hours has elapsed since missing a dose at the normal time, the patient should not take the dose, but take the next dose at the normal time on the following day.

• Thromboembolic Events

  • Thromboprophylaxis should be administered for at least the first 5 months of treatment, especially in patients with additional thrombotic risk factors. Prophylactic antithrombotic medicinal products, such as low molecular weight heparins or warfarin, should be recommended. The decision to take antithrombotic prophylactic measures should be made after careful assessment of an individual patient's underlying risk factors.

  • If the patient experiences any thromboembolic events during treatment with Thalidomide, discontinue treatment and start standard anticoagulation therapy. Once the patient has been stabilised on the anticoagulation treatment and any complications of the thromboembolic event have been managed, the Thalidomide treatment may be restarted at the original dose dependent upon a benefit risk assessment. The patient should continue anticoagulation therapy during the course of Thalidomide treatment.

• Peripheral Neuropathy

  • If the patient experiences peripheral neuropathy during treatment with Thalidomide in combination, treatment should be discontinued. Continue to monitor the patient and when the patient reaches Grade 1 neuropathy, the treatment may be restarted at a 50% reduction.

  • If at anytime the patient experiences Grade 3 or 4 neuropathy, the treatment should be discontinued permanently.

• Patients with Renal or Hepatic Impairment

  • No specific studies have been conducted in patients with renal or hepatic impairment. No specific dose recommendations for these patient populations are available. Patients with severe organ impairment should be carefully monitored for adverse reactions.

• Elderly Population

  • No specific dose adjustments are recommended for the elderly ≤ 75 years of age. For patients > 75 years of age, the Thalidomide recommended starting dose is 100 mg per day.

• Paediatric Population

  • There is no relevant use of Thalidomide in the paediatric population in the indication of multiple myeloma.

【CONTRAINDICATIONS】
DOMIDE are contraindicated in the following patients:

• Hypersensitivity to Thalidomide or to any of the excipients

• Pregnant women, or those who are breastfeeding

• Women of child bearing potential who are not using, not willing or not able to use adequate contraceptive measures to prevent pregnancy

• Women of childbearing potential where there is an alternative treatment of non-inferior efficacy available

• Males who are not able or willing to comply with adequate contraceptive measures