ALKERAN TABLET 2 mg (Revised formula)

Excella GmbH & Co. KG (GERMANY)🇸🇬 Health Sciences Authority

Approval Date: Feb 26, 2002
Approval ID: a1eb57eb9cda6dec
Company: Excella GmbH & Co. KG (GERMANY)
Type: Therapeutic

Approval Details

Approval Id: a1eb57eb9cda6dec
Drug Name: ALKERAN TABLET 2 mg (Revised formula)
Product Name: ALKERAN TABLET 2 mg (Revised formula)
Approval Number: SIN11822P
Approval Date: 2002-02-26
Registrant: DCH AURIGA SINGAPORE
Licence Holder: DCH AURIGA SINGAPORE
Drug Type: Therapeutic
Forensic Classification: Prescription Only
Dosage Form: TABLET, FILM COATED
Dosage: Dosage and Administration General ALKERAN is a cytotoxic drug which falls into the general class of alkylating agents. It should be prescribed only by physicians experienced in the management of malignant disease with such agents. Since ALKERAN is myelosuppressive, frequent blood counts are essential during therapy and the dosage should be delayed or adjusted if necessary (see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). The absorption of ALKERAN after oral administration is variable. Dosage may need to be cautiously increased until myelosuppression is seen, in order to ensure that potentially therapeutic levels have been reached. Multiple myeloma A typical oral dosage schedule is 0.15 mg/kg bodyweight/day in divided doses for 4 days repeated at intervals of 6 weeks. Numerous regimens have, however, been used and the scientific literature should be consulted for details. The administration of oral ALKERAN and prednisone may be more effective than ALKERAN alone. The combination is usually given on an intermittent basis. Prolonging treatment beyond one year in responders does not appear to improve results. Advanced ovarian adenocarcinoma A typical regimen is 0.2 mg/kg bodyweight/day orally for 5 days. This is repeated every 4 to 8 weeks, or as soon as the peripheral blood count has recovered. Carcinoma of the breast ALKERAN has been given orally at a dose of 0.15 mg/kg bodyweight or 6 mg/m2 body surface area/day for 5 days and repeated every 6 weeks. The dose was decreased if bone marrow toxicity was observed. Polycythaemia rubra vera For remission induction, doses of 6 to 10 mg daily for 5 to 7 days have been used, after which 2 to 4 mg daily were given until satisfactory disease control was achieved. A dose of 2 to 6 mg once per week has been used for maintenance therapy. In view of the possibility of severe myelosuppression if ALKERAN is given on a continuous basis, it is essential that frequent blood counts are taken throughout therapy, with dosage adjustment or breaks in treatment, as appropriate, to maintain careful haematological control. Use in children ALKERAN within the conventional dosage range, is only rarely indicated in children and absolute dosage guidelines cannot be provided. Use in the elderly Although ALKERAN is frequently used at conventional dosage in the elderly, there is no specific information available relating to its administration to this patient subgroup. Dosage in renal impairment (See Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). ALKERAN clearance, though variable, is decreased in renal impairment. Currently available pharmacokinetic data do not justify an absolute recommendation on dosage reduction when administering ALKERAN tablets to patients with renal impairment, but it may be prudent to use a reduced dosage initially until tolerance is established.
Route Of Administration: ORAL
Indication Info: Indications ALKERAN tablets are indicated in the treatment of: <ul> <li>multiple myeloma;</li> <li>advanced ovarian adenocarcinoma;</li> </ul> ALKERAN tablets may be used in the treatment of: <ul> <li>breast carcinoma: ALKERAN either alone or in combination with other drugs has a significant therapeutic effect in a proportion of patients suffering from advanced breast carcinoma;</li> <li>polycythaemia rubra vera: ALKERAN is effective in the treatment of a proportion of patients suffering from polycythaemia rubra vera.</li> </ul>
Contraindications: Contraindications ALKERAN should not be given to patients who have suffered a previous hypersensitivity reaction to the active substance or to any of the excipients listed in section LIST OF EXCIPIENTS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information. Do not take ALKERAN if you are breastfeeding.
Atc Code: L01AA03
Atc Item Name: melphalan
Pharma Manufacturer Name: DCH AURIGA SINGAPORE

Active Ingredients

MELPHALAN

2.00 mg

MELPHALAN

2.00 mg

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Feb 26, 2002

Approval ID

a1eb57eb9cda6dec

Type

Therapeutic

Back to HSA Approvals