Factor IX Albumin Fusion Protein Recombinant (Intravenous)

Overview

Factor IX albumin fusion protein recombinant (available under the brand name Idelvion) is a blood clotting drug. It is a synthetic medical injection that takes the place of the natural clotting factor IX in individuals with Hemophilia B. When people with congenital factor IX deficiency or Christmas disease use the medication as required, they bleed less often day to day, and prevent excessive bleeding while undergoing any surgical procedure.

The medication may be used on demand as well as routinely to manage abnormal bleeding disorders. People who experience unexplained bleeding in joints or muscles due to deficiency of the clotting factor IX may also use the Idelvion.

Studies have shown Idelvion to be safe and effective in enhancing the clotting of blood in both adults and children with congenital Factor IX deficiency. However, only a healthcare practitioner should administer or supervise the use of the artificial protein to treat Hemophilia B.

Conditions Treated

  • Hemophilia B
  • Spontaneous bleeding
  • Preoperative bleeding
  • Regular prophylaxis

Type Of Medicine

  • Hemostatic

Side Effects

According to the FDA, studies into the efficacy and safety of Idelvion revealed no significant concerns - a headache appears to be the most common side effect of the medication. A patient using the drug may also experience high body temperature, pain at the injection site, nausea, vomiting, coldness, and fatigue. These effects are not usually indicative of a severe underlying issue, but if they get worse or fail to improve, they require immediate medical attention.

Some patients swell at the site of their Idelvion injection, which is a dangerous treatment outcome that the doctor should know about as soon as it occurs. See your healthcare practitioner right away if, after receiving the medication, you notice signs of kidney damage (for example an abnormal amount of urine) or experience new or increased bleeding. Shortness of breath and swollen limbs, feet, and ankles are also potential severe side effects of the drug.

The incidence of extremely severe Idelvion side effects such as difficulty breathing and chest pain is almost negligible. Report any such treatment results to your doctor immediately after they occur. The same is true for fingers that turn bluish, a fast heartbeat, hives, pain in joints, irritation, change of skin color to red, difficulty swallowing, and hoarseness.

Keep in mind that some unpleasant effects of using factor IX albumin fusion protein recombinant are allergic reactions that affect only specific patients. If you are allergic to this medication, there is a slight chance that you may experience rashes, itching, extreme lightheadedness, and the swelling of the face, tongue, or throat. Get medical help as soon as you experience any of these severe effects while taking Idelvion.

Dosage

The amount or strength of Idelvion that a patient receives depends on their specific circumstances. Your doctor will assess the severity of your clotting factor IX deficiency, response to treatment, age, and the site/degree of bleeding before prescribing an appropriate dose. For example, the dosage for treating spontaneous bleeding is not the same as that for tooth extraction or major surgery.

A qualified healthcare practitioner gives the factor IX albumin fusion protein recombinant injection to the patient. During administration, the caregiver draws the medication in a dissolved form into a syringe. Using a medical needle attached to the syringe, they inject the drug through a vein into the bloodstream. The procedure may last a couple of minutes depending on the prescription.

A healthcare expert may also train the patient to give the medication at home. Be sure to receive all the appropriate preparation and administration directives from your doctor or pharmacist if you will be giving yourself the Idelvion injection. The product comes with a patient information leaflet you should read before you can start using the treatment.

Major Drug Interactions:

Factor IX albumin fusion protein recombinant may interact with other medicines, substances, and foods. The outcome of such interactions may be the ineffectiveness of the medication or mild to severe side effects. As such, your doctor will seek to know about any other drugs you are taking before determining whether to give you Idelvion. The healthcare practitioner may have to stop or change the dosage of either or both of the medications you are using.

Idelvion may react with other clotting medication such as:

  • Tranexamic acid
  • Aminocaproic acid

Warnings

A patient has to keep visiting their doctor regularly for the assessment of their response to treatment with factor IX albumin fusion protein recombinant. They should take any necessary blood and urine tests to monitor any possible side effects.

If your body creates antibodies that work against factor IX, you may not receive optimal treatment benefits with Idelvion. In that case, you may need periodic screening for the presence of such inhibitors in your system while taking the drug.

Factor IX albumin fusion protein recombinant may not work correctly or it may cause complications if the user has other health conditions. To be on the safe side, the patient should reveal their complete medical history to their doctor before beginning treatment with Idelvion.

Patients with the deficiency of factors II, VII, VIII, or X cannot treat their condition with Idelvion. Likewise, the medication is not for treating factor complications such as inhibitor to factor XIII.

If an individual suffers a clotting problem or excessive bleeding after using blood thinners such as warfarin, they cannot treat the effects with factor IX albumin fusion protein recombinant. Also, a patient should not use this medication to treat excessive bleeding if liver complications are the cause of their clotting problem.

Due to the possible presence of inactive ingredients in Idelvion that may cause allergic complications, the doctor must take into account all reported allergies before giving the medication to a patient. For example, an individual with a hamster protein allergy should not use this drug.

If you are prone to blood clots or have suffered a clot-related condition in the past, let your doctor know. Similarly, there is need for caution before using Idelvion in patients with fibrinolysis, liver disease, or nephrotic syndrome.

Let your doctor or dentist know you are taking Idelvion before any surgery.

The medication may pose some risks to an unborn child, so a pregnant patient should only use it if necessary after comprehensive discussions about it with their doctor.

It is not clear how likely it is for factor IX albumin fusion protein recombinant to contaminate breast milk and pose a danger to a breastfeeding baby. Your doctor may clarify the risks involved in case you have to breastfeed while taking the medication.

Some of the allergic reactions that factor IX albumin fusion protein recombinant may cause are life-threatening. For example, anaphylaxis may result in fatalities in adults as well as children. Report to your doctor any potentially fatal side effects you experience after receiving an Idelvion injection, including dizziness, chest discomfort, a fast heart rate, breathing complications, or itching skin. The deadly symptoms require that you stop using the treatment until you receive further directions from your caregiver.

While Idelvion enhances blood clotting, it may also cause unusual clot-related problems in your circulation system. You are likely suffering such adverse treatment effects if, while taking the factor IX drug, you experience a severe headache, shortness of breath, low blood pressure, or chest pain. Move with speed and get treated if you feel weak or numb, or develop eyesight or speech difficulty as you receive the medication.

Both adults and children require immediate medical attention if their use of factor IX albumin fusion protein recombinant results in unexplained bleeding.

Storage

You do not have to store Idelvion if you are receiving the injection at the hospital or any other healthcare facility. In case of self-administered medication, consult your doctor about the safe storage and disposal of the medical supplies.

After using the drug in the vial, discard it along with the supplies (including the needle). Never use the package twice.

Summary

The primary objective of factor IX albumin fusion protein recombinant is to enable the clotting of blood in people with hemophilia B. Taking the medication helps stop or control spontaneous bleeding as well as bleeding during surgical/invasive procedures, including tooth extraction. The doctor may prescribe the drug for a one-off, on-demand injection or routine use.

A qualified healthcare practitioner gives the Idelvion intravenous injection, or the patient may self-administer it. Any home-based use of this medication requires training and approval from a doctor. The drug can work for both adults and children with hemophilia B.

Factor IX albumin fusion protein recombinant is safe for use, and most patients who are taking it experience bleeding episodes less often without any significant unfavorable effects except for headaches. However, the drug can trigger allergic reactions that are potentially fatal, requiring immediate medical intervention.

Quickly contact the FDA on 1-800-FDA-1088 to report any side effects you suffer while using factor IX albumin fusion protein recombinant.