Cuvitru Solution

Cuvitru belongs to a class of medicines called human normal immunoglobulin. Immunoglobulins are also known as antibodies and are found in healthy people’s blood. Antibodies are part of the immune system (the body’s natural defenses and helps your body to fight infections. Cuvitru is used in patients with a weak immune system, who don’t have enough antibodies in their blood and tend to get frequent infections. Regular and sufficient doses of Cuvitru can raise abnormally low immunoglobulin levels in your blood to normal levels (replacement therapy).

• Patients who have an inborn lack of antibody production (primary immunodeficiency syndrome).
• Patients who experience severe or recurrent infections due to a weakened immune system resulting from other conditions or treatments (secondary immunodeficiency syndromes).

CUVITRU should not be administered to/by you:

• If you are hypersensitive to immunoglobulins or to any of the other ingredients of Cuvitru (listed in section 6).
• If you have a severe immunoglobulin A (IgA) deficiency and a history of hypersensitivity to human immunoglobulin treatment.
• into a blood vessel (intravenously) or a muscle (intramuscularly).

Warnings and precautions

Talk to your doctor or healthcare professional before being given the injection. If Cuvitru remains in a siliconized syringe for more than two hours, visible particles may form. The detailed instructions given in the Method and Route of administration in section 3 of this leaflet must be closely followed.

Allergic reactions: You may be allergic to immunoglobulins without knowing it. Allergic reactions such as a sudden fall in blood pressure or anaphylactic shock (a sharp fall in blood pressure with other symptoms such as swelling of the throat, breathing difficulties and skin rash) are rare but they can occur occasionally even if you have not previously had problems with similar treatments. You are at increased risk of allergic reactions if you have IgA deficiency with anti IgA antibodies. Tell your doctor or nurse prior to treatment if you have IgA deficiency. Cuvitru contains residual amounts of IgA which may increase the risk of an allergic reaction.

Signs or symptoms of these rare allergic reactions include:

• feeling lightheaded, dizzy or faint
• skin rash and itchiness, swelling in the mouth or throat, difficulty breathing, wheezing
• abnormal heart rate, chest pain, blueness of lips or fingers and toes
• blurred vision

Your doctor or healthcare professional will first infuse Cuvitru slowly and carefully monitor you throughout the first infusion so that any allergic reactions can be detected and treated immediately. If you notice any of these signs during the infusion, tell your doctor or nurse immediately. He or she will decide whether to slow down the infusion rate or stop the infusion completely.

Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. Cuvitru has to be infused under the skin (subcutaneous or SC administration). Treatment with Cuvitru will be started by your doctor or nurse, but you may be allowed to use the medicine at home once you have received the first few infusions under medical supervision and you (and/or your caregiver) have been adequately trained. You and your doctor will decide if you can use Cuvitru at home. Do not begin treatment with Cuvitru at home until you have received complete instructions.

Dosing

Your doctor will calculate the correct dose for you based on your body weight, any previous treatment you may have received and your response to treatment. Your doctor will determine whether you need a loading dose (for adults or children) of at least 1.0 to 2.5 ml/kg of body weight divided over several days. Following this, you will be given Cuvitru on a regular basis, from daily to once every two weeks; the cumulative dose per month will be about 1.5 to 5 ml/kg of body weight. Your doctor may adjust your dose depending on your response to the treatment. Do not change the dose or dosing interval without contacting your doctor. If you think you should receive Cuvitru more, or less frequently, please speak to your doctor. If you think you have missed a dose, please speak to your doctor as soon as possible.

Starting treatment

Your treatment will be started by a doctor or nurse experienced in treating patients with a weak immune system and in guiding patients for home treatment. You will be watched carefully throughout the infusion and for at least 1 hour after stopping the infusion to see how well you tolerate the medicine. In the beginning your doctor or nurse will use a slow infusion speed and gradually increase it during the first infusion and in the following infusions. Once the doctor or nurse has found the right dose and speed of infusion for you, you may be allowed to give the treatment to yourself at home.

Home treatment

Cuvitru can be administered by yourself or your caregiver. You will be trained by a doctor or nurse experienced in the guidance and treatment of patients like you. The doctor or nurse will be with you for the first few treatments. You or your caregiver will be instructed in:

• germ free (aseptic) infusion techniques,
• the use of an administration device (if needed),
• keeping a treatment diary, and
• measures to be taken in case of severe side effects.

You must carefully follow your doctor’s instructions regarding the dose, infusion speed and schedule for infusing Cuvitru so that your treatment works for you.

Cuvitru can have the side effects. Adverse reactions such as chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, joint pain (arthralgia), low blood pressure and moderate low back pain may occur occasionally but not everybody gets them. Certain side effects, such as headache, chills, or body aches, may be reduced by slowing the infusion rate.

Should your general health worsen or if you experience any untoward effects while taking Cuvitru, please consult your doctor, pharmacist or other healthcare professional for advice.

Serious side effects

Infusions of medicines like Cuvitru can occasionally result in serious, but rare, allergic reactions. You may experience a sudden fall in blood pressure and, in isolated cases, anaphylactic shock. Doctors are aware of these possible side effects and will monitor you during and after the initial infusions. Tell your doctor or nurse immediately if you notice any of the following:

• feeling light-headed, dizzy or faint,
• skin rash and itchiness, swelling in the mouth or throat, difficulty breathing, wheezing,
• abnormal heart rate, chest pain, blueness of lips or fingers and toes,
• blurred vision

These are all very serious side effects. If you have them, you may have had a serious reaction to Cuvitru. When using Cuvitru at home, you may perform the infusion in the presence of your caregiver who will help you watch out for allergic reactions, stop the infusion, and get help if necessary. Please also see section 2 of this leaflet about the risk of allergic reactions and using Cuvitru at home.

The following side effects are very common (may affect more than 1 in 10 people):

• headache
• diarrhoea, and nausea
• redness, and pain at the site of infusion
• tiredness

The following side effects are common (may affect more than 1 in 100 people):

• dizziness, migraine, and drowsiness
• decreased blood pressure
• abdominal pain
• itching, and rash
• muscular pain
• swelling, itching, rash, and bruising at the site of infusion
• pain

The following side effects are uncommon (may affect more than 1 in 1000 people):

• burning sensation
• abdominal pain lower
• oedema at the site of infusion
• positive blood tests for antibodies

Side effects seen with similar medicines

The following side effects have been observed with infusion of human normal immunoglobulin given under the skin (subcutaneously). Although these side effects have so far not been seen with Cuvitru, it is possible that someone using Cuvitru may get them.

• tingling
• trembling
• fast heartbeat
• shortness of breath
• vocal cord dysfunction
• pain in chest
• hardening and/or warmth at the site of infusion

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of CUVITRU.

Store all medicines out of reach of children.

• Store at or below 25 °C
• Do not freeze.
• Keep the vials in the outer carton in order to protect from light.

In case the product is stored in a refrigerator, the unopened vials must be removed from refrigeration and placed at room temperature for a minimum of 90 minutes prior to use. Do not use heating devices including microwaves. Do not use this medicine if you notice that the solution is cloudy, has particles or changed colour. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewage systems (e.g. toilets).