Factor IX — Membership Pricing

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About Factor IX

Factor IX is a critical medication used to treat Hemophilia B, a genetic bleeding disorder. This vital therapy helps individuals manage and prevent serious bleeding episodes. At TheDrugClub, we understand the significant financial burden such specialized medications can pose. Our mission is to help members navigate these costs, ensuring access to necessary treatments like Factor IX through various savings options.

The information above is for educational purposes only and does not constitute medical advice. Consult your healthcare provider before making medication decisions.

What Factor IX is approved for (FDA label)

IXINITY, Coagulation Factor IX (Recombinant), is a human blood coagulation factor indicated in adults and children with hemophilia B for: On-demand treatment and control of bleeding episodes Perioperative management Routine prophylaxis to reduce the frequency of bleeding episodes IXINITY is not indicated for induction of immune tolerance in patients with hemophilia B [see Warnings and Precautions ( 5.3 ) ]. IXINITY, Coagulation Factor IX (Recombinant), is a human blood coagulation factor indicated in adults and children with hemophilia B for: On-demand treatment and control of bleeding episodes ( 1 ) Perioperative management ( 1 ) Routine prophylaxis to reduce the frequency of bleeding episodes ( 1 ) IXINITY is not indicated for induction of immune tolerance in patients with hemophilia B. ( 1 )

Source: Read the full FDA label on DailyMed. Label effective date: April 3, 2024.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Dosage forms and strengths for Factor IX (FDA label)

IXINITY is available as a lyophilized white or almost white powder, in single-dose glass vials containing nominally 250, 500, 1000, 1500, 2000, or 3000 IU per vial. IXINITY is available as a lyophilized white or almost white powder, in single-dose glass vials containing nominally 250, 500, 1000, 1500, 2000, or 3000 international units (IU) per vial (3)

Source: FDA prescribing information (DailyMed). Set ID: 26bc221d-c9bc-4aba-92f3-6c21acaaf194. SPL document ID: 5e2b1242-2977-463b-ac2c-f89dadfba407. Label effective date: April 3, 2024. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Adverse reactions for Factor IX (FDA label)

The most common adverse reaction (> 2%) reported in clinical trials was headache. The most common adverse reaction observed in > 2% of patients in clinical trials was headache ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Medexus Pharma, Inc. at 1-844-859-6675 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Source: FDA prescribing information (DailyMed). Set ID: 26bc221d-c9bc-4aba-92f3-6c21acaaf194. SPL document ID: 5e2b1242-2977-463b-ac2c-f89dadfba407. Label effective date: April 3, 2024. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Contraindications for Factor IX (FDA label)

IXINITY is contraindicated in patients who have known hypersensitivity to IXINITY or its excipients, including hamster protein [see Warnings and Precautions (5.1) ]. Do not use in patients with known hypersensitivity to IXINITY or its excipients, including hamster protein ( 4 )

Source: FDA prescribing information (DailyMed). Set ID: 26bc221d-c9bc-4aba-92f3-6c21acaaf194. SPL document ID: 5e2b1242-2977-463b-ac2c-f89dadfba407. Label effective date: April 3, 2024. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Warnings and precautions for Factor IX (FDA label)

Hypersensitivity reactions, including anaphylaxis has occurred. Should symptoms occur, discontinue IXINITY and administer appropriate treatment. Patients may also develop hypersensitivity to hamster (CHO) protein, which is present in trace amounts in the product ( 5.1 ) Development of neutralizing antibodies (inhibitors) to IXINITY may occur. If expected factor IX activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, perform an assay that measures factor IX inhibitor concentration ( 5.2 ) Nephrotic syndrome has been reported following immune tolerance induction with factor IX products in hemophilia B patients with factor IX inhibitors ( 5.3 ) Thromboembolism has occurred with IXINITY use ( 5.4 ) 5.1 Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis, has occurred with IXINITY. Signs of allergic reactions, which can progress to anaphylaxis, include urticaria, angioedema, chest or throat tightness, hypotension, lethargy, nausea, vomiting, dysphagia, paresthesia, restlessness, wheezing and dyspnea.

Source: FDA prescribing information (DailyMed). Set ID: 26bc221d-c9bc-4aba-92f3-6c21acaaf194. SPL document ID: 5e2b1242-2977-463b-ac2c-f89dadfba407. Label effective date: April 3, 2024. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.