powder and solvent for solution for injection
octocog alfa recombinant human coagulation factor VIII

What Kovaltry is and what it is used for

Kovaltry contains the active substance recombinant human factor VIII (octocog alfa). Kovaltry is produced by recombinant DNA technology without the addition of any human or animal components in the manufacturing process. Factor VIII is a protein found naturally in the blood that helps it to coagulate.

Kovaltry is used to treat and prevent bleeding in adults, adolescents, and children of all ages with type hemophilia (hereditary factor VIII deficiency ).

What you need to know before using Kovaltry

Do not use Kovaltry

  • if you are allergic to octocog alfa or any of the other ingredients of this medicine (listed in section 6).
  • if you are allergic to protein you from mouse or hamster.

Warnings and cautions

Talk to your doctor or pharmacist if you have:

  • pressure over the chest, feeling dizzy (when you get up from a sitting or lying position), itchy hives , wheezing, feeling nauseous or fainting. This may be a sign of a rare, severe, sudden allergic reaction to Kovaltry. vbryt administering the product immediately and see your doctor immediately if this occurs.
  • a bleeding that can not be controlled using your usual dose of Kovaltry. Development of inhibitors ( antibodies ) is a known complication that can occur during treatment with any factor VIII drug. The inhibitors prevent, especially at high levels, that the treatment works properly. Patients receiving Kovaltry will be closely monitored for the development of such inhibitors. If you or your child has a haemorrhage that cannot be controlled with Kovaltry, tell your doctor immediately.
  • developed factor VIII inhibitor previously when using another drug. There is a risk that the inhibitor will come back if you switch between different factor VIII drugs.
  • confirmed heart disease or are at risk of heart disease
  • a central venous catheter to deliver Kovaltry. You may be at risk for catheter-related complications where the catheter is inserted in the form of:local infection is- bacteria in the bloodformation of a blood clot in that blood vessel

Children and young people

The stated warnings apply to patients of all ages, adults, and children.

Other medicines and Kovaltry

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.

Kovaltry is unlikely to affect the fertility of male or female patients as the active substance is found naturally in the body.

Driving and using machines

If you experience dizziness or other symptoms that affect your ability to concentrate and react, do not drive or use machines until the symptoms subside.

Kovaltry contains sodium

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

How to use Kovaltry

Treatment with Kovaltry is started by a doctor who has experience in the treatment of patients with hemophilia. Always use this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.

Dose one of factor VIII units is measured in international units (IU).

Treatment of bleeding

To treat bleeding, the doctor calculates and adjusts the dose and how often it should be given based on factors such as:

  • your weight
  • severity of hemophilia A
  • where it is bleeding and how severe the bleeding is
  • if you have inhibitors and how high their level is
  • the factor VIII level required

Prevent bleeding

If you are being given Kovaltry to prevent bleeding, your doctor will calculate a dose for you. Dose one is usually 20 – 40 IU octocog alfa per kg body weight and is injected two or three times a week. In some cases, especially younger patients, however, may need to be dosed more often or at higher doses.

Laboratory tests

Laboratory tests at appropriate intervals will help ensure that you have adequate factor VIII levels. Particularly in the case of major surgical procedures, the coagulation capacity of the blood must be closely monitored.

Use for children and adolescents

Kovaltry can be used for children of all ages. Children under the age of 12 may need higher doses or be injected more often than prescribed for adults.

Patients with inhibitors

If you have developed factor VIII inhibitors, you may need to use a higher dose to achieve bleeding control. If the increased dose does not reduce the bleeding, your doctor may consider giving you another medicine.

Talk to your doctor for more information.

Do not increase the dose of a Kovaltry to be able to control the bleeding without consulting your doctor.

Duration of treatment

Most often, treatment with Kovaltry for hemophilia is a lifelong treatment.

How to use Kovaltry

Kovaltry is injected into a vein (2 to 5 minutes) depending on the total volume and taking into account what feels comfortable for you. The drug should be used within 3 hours after reconstitution.

How Kovaltry is prepared for administration

Use only the components (vial adapter, pre-filled syringe containing diluent, and infusion set) that come with each pack of this medicine. Contact a doctor if these components cannot be used.

Do not use if any of the supplied components in the package have been opened or damaged.

The reconstituted product must be filtered using the vial adapter before administration so that any particles in the solution are removed.

Do not use the supplied infusion set to draw blood as it contains a built-in filter.

This medicine must not be mixed with other infusion fluids. Do not use solutions with visible particles or that are cloudy. Carefully follow the doctor’s instructions for use and the instructions for use at the end of this leaflet.

If you use more Kovaltry than you should 

Talk to your doctor if this happens. No overdose symptoms have been reported.

If you forget to use Kovaltry

  • Take the next dose immediately and continue at regular intervals according to your doctor’s prescription.
  • Do not use a double dose to make up for a forgotten dose .

If you want to stop using Kovaltry

Do not stop using this medicine without consulting a doctor.

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

What you need to know before using Kovaltry

Possible side effects5.

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

The most serious side effects are allergic reactions which can be severe allergic reactions. Discontinue injection of Kovaltry immediately and contact a doctor immediately if such reactions occur.

The following symptoms  may be an early warning for these reactions:

  • pressure over the chest / general malaise
  • dizziness
  • feeling dizzy when standing up indicating a drop in blood pressure
  • nausea

In children who have not previously been treated with factor VIII, it is very common for inhibitor antibodies (see section 2) to form (may occur in more than 1 in 10 patients). In patients who have previously been treated with factor VIII (more than 150 days of treatment), inhibitor antibodies may be formed (see section 2). This complication is classified as uncommon (affects less than 1 user in 100). If this happens, your medication may stop working properly and you may experience persistent bleeding. If this happens, consult a doctor immediately.

Other possible side effects:

Common (may affect up to 1 in 10 people):

  • swollen lymph nodes (swelling under the skin of the neck, armpits or groin)
  • palpitation er (you feel your heart beating hard, fast or irregularly)
  • fast pulse
  • abdominal pain or stomach upset
  • indigestion
  • fever
  • local reaction at the injection site (eg subcutaneous bleeding, intense itching , swelling, burning sensation, transient redness of the skin)
  • headache
  • difficulty sleeping
  • rash / itchy rash.

Uncommon ( may affect up to 1 in 100 people):

  • dysgeusi (taste disturbances)
  • urticaria (itchy rash)
  • hemorrhage ( redness of the face)

How to store Kovaltry

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 labels and cartons. The expiration date is the last day of the specified month.

Store in a refrigerator (2 ° C – 8 ° C). Do not freeze.

Store in the original package. Sensitive to light.

This medicinal product can be stored at room temperature (at a maximum of 25 ° C) for up to 12 months, provided it is stored in the outer carton. If you store it at room temperature, it will expire 12 months after the first room storage date or at the expiry date on the packaging if this occurs first. The new expiry date must be stated on the outer carton when the medicine is taken out of the refrigerator.

Do not refrigerate the solution after reconstitution. The reconstituted solution must be used within 3 hours. This medicine is for single use only. Any unused product should be discarded.

Do not use this medicine if the solution contains particles or if the solution is cloudy.

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.

Contents of the pack and other information

Content declaration

The active substance is octocog alfa ( human coagulation factor VIII).

Each vial of Kovaltry nominally contains 250, 500, 1,000, 2,000, or 3,000 IU octocog alfa.

The other ingredients are sucrose, histidine, glycine (E 640), sodium chloride, calcium chloride dihydrate (E 509), polysorbate 80 (E 433), glacial acetic acid (E 260), and water for injections.

What the medicine looks like and contents of the pack

Kovaltry is supplied as a powder and solvent for solution for injection.

The powder is dry and white to off-yellow. The diluent is a clear liquid.

Each pack of Kovaltry contains:

  • a glass vial of powder 
  • a pre-filled syringe with diluent
  • a separate spray plunger
  • an adapter for the vial
  • an infusion set (to inject into a vein)

Kovaltry is available in the following pack sizes:

  • Pack
  • Multipack with 30 single packs 

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Holder of approved for sale

Bayer AG

51368 Leverkusen

Germany

Manufacturer

Bayer AG

Kaiser-Wilhelm-Allee

51368 Leverkusen

Germany

Contact the representative of the marketing authorization holder to find out more about this medicine:

Sweden

Bayer AB

Tel: +46 (0) 8 580 223 00

Muhammad Nadeem

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