Alkeran Tablets (Melphalan)

Adult dosage

(Tablets) ○ Adults Increase the dose carefully until bone marrow suppression is observed to confirm that the therapeutic concentration has been reached. 1. Multiple myeloma More effective when administered in combination with prednisone. Usually, administer melphalan 0.15 mg/kg of body weight daily and prednisone 40 mg orally in divided doses for 4 days; repeat at 6-week intervals. 2. Ovarian adenocarcinoma Usually, administer this medicine orally at 0.2 mg/kg of body weight daily in 3 divided doses for 5 days; repeat at 4～8-week intervals, taking bone marrow recovery into consideration. 3. Advanced breast cancer Administer this medicine orally at 0.15 mg/kg of body weight or 6 mg/㎡ daily for 4～6 days; repeat at 3～6-week intervals. Reduce the dose if bone marrow toxicity is observed. 4. Polycythemia vera For induction of remission, initially administer this medicine orally at 6～10 mg daily for 5～7 days, followed by 2～4 mg daily until satisfactory disease control is achieved. Maintenance therapy is administered weekly at 2～6 mg. During maintenance therapy, close hematologic monitoring, together with dose adjustment based on frequent blood cell counts, is essential. (Injection) ○ Adults Usually, administer melphalan 0.4 mg/kg of body weight (16 mg/㎡) intravenously over 15～20 minutes. Administer 4 doses at 2-week intervals, then, if the patient has adequately recovered from toxicity, administer at 4-week intervals. As the therapeutic effect may develop slowly over several months, repeated administration may be necessary. During long-term administration of this medicine, dose adjustment based on blood cell counts is required. ○ Patients with renal impairment (BUN＞30 mg/dL) Reduce the dose to 1/2.

This drug is a potent cytotoxic agent and must be used under the guidance of an experienced physician. Due to its strong bone marrow-suppressing effect, blood leukocyte and platelet counts should be frequently monitored to avoid abnormalities. Even after discontinuation, blood cell counts may continue to decline, so treatment should be stopped immediately if early signs of abnormally low blood counts appear. The risk of thrombosis may increase when used with other specific medications, so the physician should carefully assess the patient's condition to determine the need for anticoagulant therapy. This medication is not used in patients with severely low leukocyte counts or reduced platelet counts, or in those with a history of allergic reactions to this drug. Caution is advised when administering to patients with infections, impaired renal function, or those who have recently undergone radiation or chemotherapy. This drug may cause gastrointestinal symptoms such as nausea, vomiting, diarrhea, stomatitis, as well as hair loss, skin rash, hepatic dysfunction, and pulmonary disease, so the physician should be consulted if symptoms arise. Women who are pregnant or may become pregnant should avoid use or administer very cautiously due to potential risk to the fetus, and men should also consider contraception as it may affect reproductive function. There is no specific antidote for overdose, so blood status should be carefully monitored over a long period, and appropriate treatment should be taken if necessary. The safety and efficacy of this drug in children have not been sufficiently confirmed, and dosages for the elderly should be adjusted considering renal or hepatic function. Store out of reach of children, in a tightly sealed container protected from light, and do not transfer to other containers from the original packaging.

Leukopenia, thrombocytopenia, anemia, hemolytic anemia, loss of appetite, nausea, vomiting, diarrhea, stomatitis, gastroenteritis, abnormal liver function tests, hepatitis, jaundice, skin hypersensitivity reactions, vasculitis, alopecia, itching, papular rash, interstitial pneumonia, pulmonary fibrosis, urticaria, edema, skin rash, anaphylactic shock, cardiac arrest, infection risk, elevated blood urea, sepsis, injection site ulcer, skin necrosis, localized warmth and numbness at the injection site, tachycardia, bronchospasm, dyspnea, hypotension, mucositis, stomatitis, colitis, gastrointestinal bleeding, elevated liver enzymes, venous occlusive disease, nephrotoxicity, dyspnea, hyponatremia, loss of consciousness, seizures, muscle paralysis, cholinergic effects

This drug is sensitive to light and should be stored in a tightly sealed container that blocks light. Additionally, it should be stored at refrigeration temperatures between 2 to 8 degrees Celsius to maintain efficacy.

Appearance

White to grayish-white, biconvex round film-coated tablet

Package unit

25 tablets/bottle