ANDEXXA is indicated for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. ANDEXXA (coagulation factor Xa (recombinant) can be imported for personal use under "patient name basis" treatment in India. For this applicant is required to make an request application with required document. IPN, New Delhi will do the necessary process to obtain permission from Drugs Controller General (India) to import.
Therapeutic indications and Usage
ANDEXXA (coagulation factor Xa (recombinant), inactivated-zhzo) is a recombinant modified human factor Xa (FXa) protein indicated for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. This indication is approved under accelerated approval based on the change from baseline in anti-FXa activity in healthy volunteers. An improvement in hemostasis has not been established. Continued approval for this indication may be contingent upon the results of studies that demonstrate an improvement in hemostasis in patients.
DISEASE INDICATIONS : uncontrolled bleeding
MANUFACTURER: Alexion Pharmaceuticals, Inc
DOSAGE FORMS AND STRENGTHS: DOSAGE FORMS AND STRENGTHS: lyophilized powder in single-use vials of 200 mg of coagulation factor Xa (recombinant), inactivated-zhzo.
MEDICINE APPROVED BY : Food and Drug Administration (FDA)
Source Details: Patient Information
Patient Name Basis Treatment IPN, New Delhi can facilitate patient to import of "ANDEXXA (coagulation factor Xa (recombinant)" in quantities for personal use. For this applicant is required to make an application in Form 12A, along with the prescription of the Registered Medical Practitioner (RMP).
Health Professional In India
If you have any question, please email IPN Support Team or Call Indian Pharma Network for ANDEXXA (coagulation factor Xa (recombinant) price list or cost in India. on
Mr. Tarun:- +91 9891 296 838 (Patient Support)
Mr. Neeraj:- +91 9811 747 774 (Patient Support)
We are the facilitator, group of highly qualified healthcare professionals, provide solutions on how to get access of anti cancer medicines not available in India. On the basis of permission in Form 12B (Import permit) from From Ministry of Health, Government of India, IPN, New Delhi procure drugs on behalf of patient.
Coagulation factor Xa (recombinant), inactivated-zhzo exerts its procoagulant effect by binding and sequestering the FXa inhibitors, rivaroxaban and apixaban. Another observed procoagulant effect of the ANDEXXA protein is its ability to bind to, and inhibit the activity of, Tissue Factor Pathway Inhibitor (TFPI). Inhibition of TFPI activity can increase tissue factor (TF)-initiated thrombin generation. Coagulation factor Xa (recombinant), inactivated-zhzo injection is used to treat life-threatening or uncontrolled bleeding in patients who are receiving other medicines (including apixaban and rivaroxaban). This medicine is to be given only by or under the supervision of your doctor or other health care professional. This product is available in the following dosage forms:Powder for Solution
Source content : www.accessdata.fda.gov
IPN, New Delhi can facilitate patient to import of "ANDEXXA (coagulation factor Xa (recombinant)" in quantities for personal use. Expertise in Specialty Pharmaceutical distribution having its PAN India presence in Delhi, Mumbai, Kolkata, Chennai, Bangalore, Hyderabad, Ahmedabad, Pune, Visakhapatnam, Surat, Jaipur, Coimbatore, Kanpur, Nagpur, Raipur, Kochi, Kozhikode, Nashik, Salem, Thiruvananthapuram, Madurai, Jodhpur, Noida, Gurgaon, Punjab, Chandigarh, Bhubaneswar, Arunachal Pradesh, Assam, Manipur, Meghalaya, Mizoram, Nagaland, Tripura and Sikkim, India. with over 20 years of domain experience.
For procurement cost of ANDEXXA (coagulation factor Xa (recombinant) in India, Please call at M: +91 9811747774 (Mr. Tarun) / 9891296838 (Mr. Neeraj) or Email Us to know more details about the ANDEXXA (coagulation factor Xa (recombinant) medicine cost price in India.
The order for ANDEXXA (coagulation factor Xa (recombinant) will be confirmed only after
1. submitting Form 12A, along with the prescription of the Registered Medical Practitioner (RMP).
2. Permission from obtained from the office of the Drugs Controller General (India).
3. Availability of ANDEXXA (coagulation factor Xa (recombinant) from authorised distributor.
Coagulation factor Xa (recombinant), inactivated-zhzo (formally known as “andexanet alfa”) is approved by the Food and Drug Administration (FDA) for use in patients treated with the factor Xa inhibitors apixaban and rivaroxaban, when acute reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
ANDEXXA (coagulation factor Xa (recombinant), inactivated-zhzo) is a sterile, white to off-white lyophilized powder available in single-use vials, containing 100 mg of coagulation factor Xa formulated with the inactive ingredients tromethamine (Tris), L-arginine hydrochloride, sucrose (2% w/v), mannitol (5% w/v), and polysorbate 80 (0.01% w/v) at pH 7.8. After reconstitution of the lyophilized powder with sterile Water for Injection for intravenous (IV) administration, the product is a clear, colorless to slightly yellow solution. ANDEXXA contains no preservatives.
The active ingredient in ANDEXXA is a genetically modified variant of human Factor Xa. The active site serine was substituted with alanine, rendering the molecule unable to cleave and activate prothrombin. The gamma-carboxyglutamic acid (Gla) domain was removed to eliminate the protein’s ability to assemble into the prothrombinase complex, thus removing the potential anti-coagulant effects.
No additives of human or animal origin are used in the manufacture of ANDEXXA. The recombinant protein is produced in a genetically engineered Chinese Hamster Ovary (CHO) cell expression system and has a molecular weight of approximately 41 kDa. The manufacturing process incorporates two validated virus clearance steps.
Source Details: Patient Support Information
ANDEXXA (coagulation factor Xa (recombinant), inactivated-zhzo) Lyophilized powder for solution for intravenous injection Initial U.S. Approval: 2018
ANDEXXA is available as a lyophilized powder in single-use vials of 200 mg of coagulation factor Xa (recombinant), inactivated-zhzo.
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Step 1. Send a request for your medicine online:-
Applicant is required to make an application in Form 12A, along with the prescription of the Registered Medical Practitioner (RMP).Step 2. Verification of documents:-
We verify your a prescription and necessary documents to import drugs in quantities for personal use.Step 3. Permission to Import:-
After getting approval of Drugs Controller General (India), we start the process to import of drugs as mentioned in prescription for personal use.Step 4. We source your medicine:-
Our expert sourcing team work with our global network of suppliers to find you the best price. Once we have found you the lowest possible cost for your medicine, we will present you with a final offer for your approval.Step 5. Delivery of medicine:-
After you have accepted our offer, our experienced logistics team will arrange all the shipping and transportation of your medicine. Doctor’s Prescription –
We would require prescription from Registered Medical Practitioner (RMP) stating product name, dosage, duration of treatment and diagnosis.
Patient’s Medical history –
We would require all test reports and medical reports of the patient for last 3 months.
Patient’s Identity card –
We will require scan copy of patient’s identity card and proof of residence to initiate documentation process.
Almost all countries across the world have provisions for granting access to drugs prior to marketing approval for personal use for patients who have exhausted all other treatment options available in their country. Indian Pharma Network, New Delhi can help patients in accessing/importing Ant-cancer medicines, unapproved in their home country against a legitimate prescription and in conformity with all local laws and regulations of their home country.
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Your order will be shipped to you by our partner couriers, such as DHL, UPS and specialised cold chain couriers. If you would like your order to be shipped by a specific courier, please inform us when you place the order. Our standard delivery time varies from 5 to 10 working days. The shipping cost depends on the medicine and the destination country. After making an enquiry, you will receive a detailed quote that includes the shipping costs.
