Detailed patient information for the ALS drug Rozebalamin (methylcobalamin)

Drug name

Trade name:Rozebalamin

Common name: Mecobalamin (Mecobalamin)

English name:Mecobalamin

Chinese name: Methylcobalamin

Japanese name: メコバラミン

1.Manufacturer

Eisai Co., Ltd. (Eisai Co., Ltd.)

2.Drug composition

The main ingredient of this product is methylcobalamin (Mecobalamin). Each bottle contains 25mg of methylcobalamin.

3.Indications

Rozebalaminis used to treat amyotrophic lateral sclerosis (ALS) by slowing the progression of functional impairment. ALS is a neurodegenerative disease that affects motor nerves, causing muscle weakness and atrophy, and may lead to respiratory failure. Through its neuroprotective effects, methylcobalamin may improve neurological function and delay disease progression.

4.Usage and Dosage

Rozebalamin is administered by intramuscular injection. The recommended dose for adult patients is once daily50mg (i.e. 2 bottles), twice a week. The specific dosage regimen should be adjusted by the doctor based on the patient's individual condition.

Standard dosage: 50mg each time (i.e. 2 bottles), once a day, it is recommended to inject twice a week. The total monthly therapeutic dose is 16 bottles (2 boxes).

Frequency of use: There should be at least one day between each injection, for example, Monday for the first injection and Thursday for the second.

Usage: This product should be used by professional medical staff in medical facilities. Patients need to receive relevant training when starting treatment to ensure safe and effective injection methods. If patients need to self-inject themselves at home, they must do so under the guidance of medical staff and be fully trained.

5.Drug Preparation

Rozebalamin is a lyophilized powder that needs to be dissolved before use.

Dissolution solution: Use physiological saline to dissolve the drug. Each bottle of drug requires 2.3mL of physiological saline. The dose after dissolution is 2.0mL.

Note: Since this product is sensitive to light, direct sunlight needs to be avoided during the dissolution process. It should be used immediately after dissolution. Dissolved medication should be injected within60 minutes. If this time is exceeded, unused medication needs to be discarded.

6.Precautions for injection administration

Injection Site:RozebalaminIntramuscular injection only. Common injection sites are the buttocks or thigh muscles.

Injection Note: During injection, repeated injections at the same site should be avoided to reduce local reactions at the injection site. Avoid inserting the needle where the nerve runs.

Injection reaction: If the patient experiences severe pain or sees blood reflux during the injection, the injection should be stopped immediately and the injection site changed.

7.Contraindications

This product is contraindicated in patients allergic to methylcobalamin or other ingredients.

Main ingredients: Mecobalamin (Mecobalamin)

Auxiliary ingredients: lactose hydrate, sodium dihydrogen phosphate hydrate, sodium hydroxide.

8.Adverse reactions

Possible side effects include:

Severe adverse reactions: anaphylactic shock reaction, such as drop in blood pressure, difficulty breathing, etc. If a severe allergic reaction occurs, the injection should be stopped immediately and appropriate emergency treatment should be carried out.

Mild adverse reactions: including injection site reactions, rash, headache, fever, sweating, etc. If you feel unwell, you should contact your doctor promptly for treatment.

Other reactions: A small number of patients may experience blood system reactions such as an increase in the number of white blood cells, which usually require regular examinations under the supervision of medical staff.

9.For use by special groups

Children: There are currently insufficient clinical trial data in children, so this product is not recommended for use in children.

Elderly patients: For elderly patients, use with caution and dosage adjustments may be necessary based on the patient's overall health and response to treatment.

10.Storage conditions

Storage method: This product should be stored at room temperature and away from direct sunlight.

Note: The shelf life of unopened medicines is 5 years. After opening, medicines should be used within 60 minutes and discarded after this time. Avoid prolonged contact when the medicine is mixed with water or other substances. Opened medicines should be kept away from light and should be stored away from light.

11.Usage Precautions

Follow doctor's advice: This product should be used strictly in accordance with the doctor's instructions. Do not adjust the dosage or change the usage regimen at will.

Adverse drug reactions: If allergic symptoms such as rash, itching, difficulty breathing, etc. occur during the injection process, you should stop using it immediately and seek medical treatment in time.

Dosage error: If too much medicine is injected by mistake, the patient should contact the doctor promptly to evaluate whether corresponding measures need to be taken.

12.Precautions for self-injection at home

For patients who need self-injection at home, medical staff must provide adequate training when starting treatment and ensure that the patient or their family members can operate it safely. Patients should regularly report their physical condition to medical staff after injection. If any abnormal reactions are found, they should contact the doctor in time.

13.Instructions for red urine

After injection, some patients may experience red urine. This is due to the ingredients in the drug affecting the color of the urine. The phenomenon is usually harmless, but patients should consult their doctor if they have any concerns.

Rozebalamin(methylcobalamin) is a drug used to treat ALSALSDrugs that slow the progression of the disease through neuroprotection. Patients need to follow the doctor's instructions when using it, and correctly implement the dosage and injection method to ensure the therapeutic effect and reduce the risk of side effects. If you encounter any discomfort during use, you should contact your doctor promptly.

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References:

[1]https://pins.japic.or.jp/pdf/newPINS/00071540.pdf

[2]https://www.eisai.com/news/2024/news202487.html