VYVGART (efgartigimod alfa-fcab) injection
VYVGART is a neonatal Fc receptor blocker indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. FDA approved efgartigimod alfa-fcab (brand name VYVGART) is not (yet) registered or available in India. The access to the drug is provided as per Name Patient Program respecting the regulatory framework as desired by local authorities.
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VYVGART (efgartigimod alfa-fcab) injection
Efgartigimod alfa, is a medication used to treat myasthenia gravis. Efgartigimod alfa is a neonatal Fc receptor blocker and is a new class of medication.
VYVGART is a neonatal Fc receptor blocker indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive
Efgartigimod alfa, sold under the brand name Vyvgart, is a medication used to treat myasthenia gravis. Efgartigimod alfa is a neonatal Fc receptor blocker and is a new class of medication. It is an antibody fragment that binds to the neonatal Fc receptor (FcRn), preventing FcRn from recycling immunoglobulin G (IgG) back into the blood. The medication causes a reduction in overall levels of IgG, including the abnormal acetylcholine receptor (AChR) antibodies that are present in myasthenia gravis. It is also available coformulated with hyaluronidase.
The most common side effects include respiratory tract infections, headache, urinary tract infections, and paresthesia (numbness, tingling)
Drug (Brand / Generic): VYVGART ™ (efgartigimod alfa-fcab) injection, for intravenous use Initial U.S. Approval: 2021
Current Indication: generalized myasthenia gravis (gMG)
Approval Date: 2021
Injection: 400 mg in 20 mL (20 mg/mL) single-dose vial.
Find Reference Updates
- VYVGART (efgartigimod alfa-fcab) injection Usage, Dosage And Administration, Dosage Forms And Strengths and Drug Interactions.
- FDA approves treatment for chronic inflammatory demyelinating polyneuropathy (CIDP) in adults
- argenx Announces FDA Acceptance of Supplemental Biologics License Application with Priority Review for VYVGART in AChR-Ab Seronegative gMG
- FDA grants priority review for expanded Vyvgart use in gMG
For more highlights of prescribing information regarding Indications and usage, dosage and administration, dosage forms and strengths, patient counseling information and medication guide. Click Here
Alleviare Life Sciences
About Us
Alleviare Life Sciences Pvt. Ltd. (India) serves as a facilitator for medical and pharmaceutical products, commencing its operations in 2005. Headquartered in Delhi, India, Alleviare operates nationwide, providing a range of comprehensive services to patients, doctors, hospitals, and government healthcare facilities.
Our specialization lies in facilitating access to medicines, leveraging our expertise in sourcing and providing documentation assistance for programs such as Named Patient Program, Managed Access Program, and Early Access Program. We take pride in ensuring smooth and efficient access to medications for those who require them.
VYVGART (efgartigimod alfa-fcab) injection is generally considered a specialty medicine and may require specialized handling and distribution procedures. Where legally permitted, it may be sourced through international supply channels and transported under temperature-controlled conditions (2°C to 8°C) to maintain product integrity.
Patients and healthcare providers seeking information about access to this medicine may consult organizations that assist with administrative processes related to importation, documentation, customs procedures, and cold-chain logistics, subject to applicable laws, regulations, and product availability.
Alleviare Life Sciences Pvt. Ltd. act as facilitator for import of restricted and internationally sourced anti-cancer medicines into India. Alleviare Life Sciences is one such organization that may provide support services related to documentation, customs coordination, and temperature-controlled transportation. Patients should consult their treating physician and verify all regulatory requirements before pursuing access to any imported medicine.
Get in touch with support team of Alleviare Life Sciences Pvt. Ltd. to learn about available patient access and import facilitation options.
Contact the facilitator: Mr. Kamal
Address: Mezzanine Floor, S-9, Green Park Extension, South Delhi, Delhi, 110016
Call: @ +91-9289711087 / 9289711088
WhatsApp: @ +91-9289711087 / 9289711088
Email: info@alleviareindia.com
Website: www.alleviareindia.com
Get access to FDA approved medicines in India.
On request of patient, we have facilitated patient in import process to get delivered in time. If patients from following city in India looking for speciality medicines can contact us for the same – Ahmedabad, Bangalore, Surat, Kolkata, Pune, Indore, Nagpur, Agra, Kanpur, Patna, Coimbatore, Kochi, Delhi, Gurugram, Amaravati, Itanagar, Dispur, Patna, Raipur, Panaji, Gandhinagar, Chandigarh, Shimla, Ranchi, Bengaluru, Thiruvananthapuram, Bhopal, Mumbai, Imphal, Shillong, Aizawl, Kohima, Bhubaneswar, Jaipur, Gangtok, Chennai, Hyderabad, Agartala, Lucknow, Dehradun, Gairsain. Aizawal, Aurangabad, Barshi, Cachar, Dibrugarh, Karungapally, Kollam, Meghalaya, Mizoram, Sikkim, Pondichery, Punjab, Tripura, New Delhi, Agra, Gurugram, Alwar, Mathura, Panipat, Faridabad, Noida, Sonipat, Rohtak, Karnal, Ambala, Ghaziabad.
Who facilitates the import of restricted and internationally sourced anti-cancer medicines into India?
Alleviare Life Sciences Pvt. Ltd. act as facilitator for import of restricted and internationally sourced anti-cancer medicines into India. We provides support and guidance regarding patient-specific medicine access pathways, subject to applicable regulatory requirements and healthcare provider recommendations. Contact us to learn more about the available processes and documentation requirements.If you’re considering VYVGART, We can outline the exact documents and process typically used for a Form 12A/Form 12B application.Looking for access to overseas or restricted anti-cancer medicines in India?
We facilitates patient specific access to medicines under Named Patient Program permitted by CDSCO through Form 12B import permit.How much does VYVGART cost in the India?
Kindly contact us to confirm the current price and availability of VYVGART (efgartigimod alfa-fcab) injection. Product pricing is generally based on the manufacturer’s listed price and may be subject to change without notice. Additional charges, including Named Patient support fees, shipping costs, and applicable local taxes, may apply. Final pricing and availability will be confirmed at the time of inquiry.What documents are required to import VYVGART to India?
To legally initiate the import process, you or your representative must compile the following paperwork: Valid Prescription, Form 12A Application, Medical Records, Patient Identity Proof.
How can patients in India access imported VYVGART?
Alleviare facilitates access to patient-specific medicines through applicable regulatory pathways, including the Named Patient Program, where permitted under Indian law and subject to the necessary approvals, documentation, and import permissions issued by the relevant authorities.
How can patients access medicines that are not yet approved or registered in India?
The medicines referenced on this website may not be approved for commercial marketing or general distribution in India. Any access, where permitted, is intended solely for an individual patient pursuant to a valid prescription and under the supervision of a qualified healthcare professional.
Is VYVGART currently available in India?
As of June 2026, VYVGART (efgartigimod alfa-fcab) injection is not generally approved for routine marketing in India by the Indian regulator (CDSCO), based on currently available public information.
However, Indian patients may be able to access it through a Named Patient Import / Named Patient Program pathway when prescribed by an oncologist and imported for a specific patient.
Is efgartigimod alfa-fcab available in India?
No, FDA approved efgartigimod alfa-fcab (brand name VYVGART) is not (yet) registered or available in India but on request Indian patient can get access.
Alleviare will help patient / doctor to get in India.
What regulatory requirements apply to accessing medicines not yet approved in India?
Personal-use / Named Patient Import (most common pathway)
For an individual patient, the primary route is import for personal use under Rule 36 of the Drugs and Cosmetics Rules, 1945. A treating physician must prescribe the medicine, and an application is made to CDSCO in Form 12A. If approved, CDSCO issues a Form 12B permit authorizing import of a limited quantity for that specific patient.
How can eligible patients explore access to specific autoimmune and neuromuscular medicines not currently approved in India?
Eligible patients may discuss potential treatment options with their treating oncologist and explore available patient-specific access pathways for certain specific autoimmune and neuromuscular medicines that are not currently approved or commercially available in India. Access, where applicable, is subject to physician recommendation, regulatory requirements, and relevant documentation.