那他珠单抗(Natalizumab)怎么购买

Natalizumab is a high-risk immunomodulatory drug, and its use must be strictly followed by medical advice and under professional medical supervision.

How to purchase Natalizumab

1. Available only through special channels

In the United States, it must be obtained through a restricted distribution program called TYRUKOREMS Program. This procedure is designed to ensure medication safety, especially against the risk of PML (Progressive Multifocal Leukoencephalopathy).

2. Requirements for prescribers and infusion centers

Prescribers must be certified by the TYRUKOREMS project and regularly evaluate whether the patient is suitable for continued medication.

Infusion centers also require certification, and patients must receive intravenous infusions every four weeks at a registered infusion center.

3. Patients must sign informed consent

Before taking medication for the first time, patients must read and sign the patient informed consent form, confirm their understanding of the drug risks, and agree to regular review and follow-up.

The pictures are from public channels (such as the official website of the FDA, the official website of the original drug manufacturer, etc.) and are for reference only.

Natalizumab medication precautions

1. PML risk assessment and monitoring

(1) Risk factors: positive anti-JCV antibodies, medication for more than 2 years, and previous use of immunosuppressants.

(2) Monitoring requirements: Brain MRI and blood antibody testing should be performed regularly before and during medication.

(3) Symptom warning: If neurological symptoms such as confusion, visual impairment, limb weakness, etc. occur, the drug should be stopped immediately and seek medical treatment.

2. Contraindications and drug interactions

(1) Absolute contraindications: It is prohibited for those who have been diagnosed with PML or are allergic to natalizumab.

(2) Combination use is prohibited: Patients with Crohn's disease cannot use immunosuppressants or TNF-α inhibitors at the same time.

3. Medication for special groups

(1) Pregnant women: It may cause neonatal thrombocytopenia, and the pros and cons need to be carefully evaluated.

(2) Lactation period: Drugs can enter breast milk. It is recommended to consult a doctor before deciding whether to breastfeed.

(3) Children and the elderly: Safety and effectiveness data have not been established and use is not recommended.

4. Infusion reaction and antibody formation

(1) Infusion reaction: headache, rash, nausea, etc. are common. In severe cases, anaphylactic shock may occur.

(2) Antibody detection: If persistent antibodies appear, it may lead to a decrease in drug efficacy or an exacerbation of allergic reactions.

Common adverse reactions of Natalizumab

1. Common reactions in patients with multiple sclerosis

Very common (≥10%): headache, fatigue, joint pain, urinary tract infection, lower respiratory tract infection, gastroenteritis, vaginitis, depression, limb pain, abdominal discomfort, diarrhea, rash, etc.

2. Common reactions in patients with Crohn's disease

Very common (≥10%): headache, upper respiratory tract infection, nausea, fatigue.

3. Serious but rare adverse reactions

(1). PML: opportunistic viral infection with high death or disability rate.

(2) Herpes infection: including encephalitis, meningitis, and acute retinal necrosis (can cause blindness).

(3) Liver damage: It can progress to liver failure and requires transplantation.

(4). Thrombocytopenia: manifested by easy bleeding, ecchymosis, and purpura.

(5) Infections related to immunosuppression: such as pneumonia, urinary tract infections, opportunistic infections, etc.