250, 500, 750, 1000, 1500, 2000, 3000, 4000 IU powder and solvent for injection , solution 
efmoroctocog alpha (alpha efmoroctocogum) ( recombinant coagulation factor VIII)

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What ELOCTA is and what it is used for 
2. What you need to know before using ELOCTA 
3. How to use ELOCTA 
4. Possible side effects 
5. How to store ELOCTA 
6. Contents of the packaging and other information 

1. What ELOCTA is and what it is used for

ELOCTA contains the active substance efmoroctocog alfa, a recombinant coagulation factor VIII Fc fusion protein. Factor VIII is a protein that is produced naturally in the body and which is necessary for the blood to be able to clot and stop bleeding.

ELOCTA is a medicine used to treat and prevent bleeding in patients of all ages with hemophilia A (hereditary hemophilia due to factor VIII deficiency ).

ELOCTA is produced by recombinant technology without the addition of any human or animal components in the manufacturing process.

How ELOCTA works

Patients with hemophilia A do not have factor VIII or the factor does not work properly. ELOCTA is used to replace the missing or malfunctioning factor VIII. ELOCTA increases the level of factor VIII in the blood and temporarily corrects the bleeding tendency.

2. What you need to know before using ELOCTA

Do not use ELOCTA:

  • if you are allergic to efmoroctocog alfa or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before using ELOCTA.

  • There is a small risk of an anaphylactic reaction (a severe, sudden allergic reaction ) to ELOCTA. Signs of allergic reactions include itching all over the body, hives, pressure on the chest, difficulty breath, ing, and low blood pressure. If any of these symptoms occur, stop the injection immediately and consult a doctor.
  • The development of inhibitors ( antibodies ) is a known complication that may occur during treatment with any factor VIII drug. The inhibitors prevent, especially at high levels, that the treatment works properly. You or your child will be closely monitored for the development of such inhibitors. If you or your child suffer from bleeding that cannot be controlled with ELOCTA, tell your doctor immediately.

Cardiovascular events

If you have heart disease or are at risk of heart disease, you should be especially careful when using factor VIII medicines and talk to your doctor.

Catheter-related complications

If you need a central venous catheter (CVK) device, the risk of CVK-related complications in the form of local infections, the presence of bacteria in the blood, and blood clots at the site of the catheter should be considered.

Documentation

It is strongly recommended that the product name and batch number be noted each time ELOCTA is given.

Other medicines and ELOCTA

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

No effects on the ability to drive and use machines have been observed.

ELOCTA contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per vial, ie essentially ‘sodium-free’.

However, depending on your body weight and dose, you may receive more than one vial. This should be considered if you have been prescribed a low-sodium diet.

3. How to use ELOCTA

Treatment with ELOCTA is initiated by a physician experienced in the management of patients with hemophilia. Always use this medicine exactly as your doctor has told you (see section 7). If you are not sure, talk to your doctor, pharmacist, or nurse.

ELOCTA is given as an injection into a vein. The doctor calculates the dose of ELOCTA (in international units or “IU”) depending on your individual needs for replacement therapy with Factor VIII and if the drug is used to prevent or treat bleeding. Talk to your doctor if you think your bleeding is not being controlled with the dose you are given.

How often you need an injection depends on how well ELOCTA works for you. Your doctor will take appropriate laboratory tests to make sure you have enough factor VIII in your blood.

Treatment of bleeding

Dose one of ELOCTA is calculated based on your body weight and the level of factor VIII to be achieved. The target level for factor VIII depends on how severe the bleeding is and where it occurs.

Prevention of bleeding

The usual dose of ELOCTA is 50 IU per kg body weight, given every 3 to 5 days. Your doctor may adjust a dose between 25 and 65 IU per kg body weight. In some cases, especially in younger patients, shorter dosing intervals or higher doses may be necessary.

Use for children and adolescents

ELOCTA can be used for children and young people of all ages. In children under 12 years of age, higher doses or more frequent injections may be needed.

If you use more ELOCTA then you should

Talk to your doctor as soon as possible. You should always use ELOCTA according to your doctor’s instructions. If you are not sure, talk to your doctor, pharmacist, or nurse.

If you forget to use ELOCTA

Do not take a double dose to make up for a forgotten dose. Take a dose as soon as you remember and then return to your normal dosing schedule. Ask your doctor or pharmacist if you are not sure what to do.

If you stop using ELOCTA

Do not stop using ELOCTA without consulting your doctor. If you stop using ELOCTA you may no longer be protected against bleeding or ongoing bleeding will not stop.

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If severe, sudden allergic reactions ( anaphylactic reaction ) occur, injection must be stopped immediately. You must contact a doctor immediately if you experience any of the following symptoms of allergic reactions: swelling of the face, skin rash, itching all over the body, hives, pressure on the chest, difficulty breathing, burning and tingling at the injection site, chills, hot flushes, headache, low blood pressure, general malaise, nausea, restlessness, and rapid heartbeat, dizziness or loss of consciousness.

Among children previously untreated with factor VIII drugs, it is very common for inhibitory antibodies to develop (see section 2) (occurs in more than 1 in 10 patients). However, for patients who have previously been treated with factor VIII (treatment for more than 150 days), the risk is less and the complication is less common (occurs in less than 1 in 100 users). With the development of antibodies, the drugs may stop working properly, and you may experience persistent bleeding. If this happens, consult a doctor immediately.

The following side effects may occur with this medicine.

Uncommon side effects (may affect up to 1 in 100 people)

Headache, dizziness, taste change, slow heartbeat, high blood pressure, hot flashes, vascular pain after injection, cough, lower abdominal pain, rash, joint swelling, muscle aches, back pain, joint pain, general discomfort, chest pain, feeling cold and low blood pressure.

5. How to store ELOCTA

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and vial label after “EXP”. The expiration date is the last day of the specified month. Do not use this medicine if it has been stored at room temperature for more than 6 months.

Store in a refrigerator (2 ° C ‑ 8 ° C).

Do not freeze.

Store in the original package. Sensitive to light.

Alternatively, ELOCTA can be stored at room temperature (maximum 30 ° C) for a continuous period of a maximum of 6 months. Make a note of the date when ELOCTA is removed from the refrigerator to room temperature on the carton. After storage at room temperature, the medicine must not be set in the refrigerator again.

Prepared ELOCTA should be used immediately. If you can not use the reconstituted solution with ELOCTA immediately, it should be used within 6 hours. Do not set the reconstituted solution in the refrigerator. Protect the reconstituted solution from direct sunlight.

The reconstituted solution will be ready to slightly pearlescent and colorless. Do not use this medicine if you notice that it is cloudy or contains visible particles.

Dispose of any remaining solution appropriately. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is efmoroctocog alfa ( recombinant coagulation factor VIII Fc fusion protein). A vial of ELOCTA nominally contains 250, 500, 750, 1000, 1500, 2,000, 3,000 or 4000 IU efmoroctocog alfa.
  • The other ingredients are sucrose, sodium chloride, histidine, calcium chloride dihydrate, polysorbate 20, sodium hydroxide, hydrochloric acid, and water for injections. If you are on a low-salt diet, see section 2.

What the medicine looks like and the contents of the pack

ELOCTA is supplied as a powder and solvent for solution for injection. The powder is a white to off-white powder or cake. The liquid provided for the preparation of the solution for injection is a clear, colorless liquid. After reconstitution, the liquid to be injected is clear to slightly pearlescent and colorless.

One pack of ELOCTA contains 1 vial of powder, 3 ml of liquid in a pre-filled syringe, 1 plunger rod, 1 vial adapter, 1 infusion set, 2 alcohol swabs, 2 patches, and 1 gauze swab.

Muhammad Nadeem

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