Deroximel DR Capsule (Enteric Coated) 231 mg

ডেরক্সিমেল ডিআর ক্যাপসুল (এন্টেরিক কোটেড) হল ডাইরোক্সিমেল ফিউমারেট ২৩১ মিলিগ্রাম সমৃদ্ধ একটি ঔষধ, যা মাল্টিপল স্ক্লেরোসিস চিকিৎসায় ব্যবহৃত হয়। রেনাটা পিএলসি প্রস্তুতকৃত এই এন্টেরিক কোটেড ক্যাপসুল পাকস্থলীর জ্বালাপোড়া কমায়। প্রতি ইউনিটের দাম ৳২০০, ৫×৬ স্ট্রিপ (৳৬,০০০) বা একক স্ট্রিপ (৳১,২০০) এ পাওয়া যায়। ৩০°C তাপমাত্রার নিচে, আলো ও আর্দ্রতা থেকে দূরে সংরক্ষণ করুন।

Blood Tests Prior to Initiation of Diroximel: Obtain the following prior to treatment with Diroximel:

• A complete blood cell count (CBC), including lymphocyte count
• Serum aminotransferase, alkaline phosphatase, and total bilirubin levels

Dosing Information: The starting dosage for Diroximel is 231 mg twice a day orally. After 7 days, the dosage should be increased to the maintenance dosage of 462 mg (administered as two 231 mg capsules) twice a day orally. Temporary dosage reductions to 231 mg twice a day may be considered for individuals who do not tolerate the maintenance dosage. Within 4 weeks, the recommended dosage of 462 mg twice a day should be resumed. Discontinuation of Diroximel should be considered for patients unable to tolerate return to the maintenance dosage. Administration of non-enteric coated aspirin (up to a dose of 325 mg) 30 minutes prior to Diroximel dosing may reduce the incidence or severity of flushing.

Administration Instructions: Swallow Diroximel capsules whole and intact. Do not crush or chew, or sprinkle the capsule contents on food. If taken with food, avoid a high-fat, high-calorie meal/snack; the meal/snack should contain no more than 700 calories and no more than 30 g fat.

The following important adverse reactions are shown:

• Anaphylaxis and Angioedema
• Progressive Multifocal Leukoencephalopathy
• Herpes Zoster and Other Serious Opportunistic Infections
• Lymphopenia
• Liver Injury
• Flushing

There are no adequate data on the developmental risk associated with the use of Diroximel or dimethyl fumarate (which has the same active metabolite as Diroximel) in pregnant women. There are no data on the presence of diroximel fumarate or metabolites (MMF, HES) in human milk. The effects on the breastfed infant and on milk production are unknown.

Anaphylaxis and Angioedema: Discontinue and do not restart diroximel if these occur.

Progressive Multifocal Leukoencephalopathy (PML): Withhold diroximel at the first sign or symptom suggestive of PML.

Herpes zoster and other serious opportunistic infections: Consider withholding diroximel in cases of serious infection until the infection has resolved.

Lymphopenia: Obtain a CBC including lymphocyte count before initiating diroximel, after 6 months, and every 6 to 12 months thereafter. Consider interruption of diroximel if lymphocyte counts <0.5 × 109/L persist for more than six months.

Liver Injury: Obtain serum aminotransferase, alkaline phosphatase, and total bilirubin levels before initiating diroximel and during treatment, as clinically indicated. Discontinue diroximel if clinically significant liver injury induced by diroximel is suspected.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Geriatric Use: Clinical studies of Dimethyl fumarate and Deroximel DR did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients.

Renal Impairment: No dosage adjustment is necessary in patients with mild renal impairment.