200 mg/ml injection solution for subcutaneous injection 
normal human

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: 
1. What Cuvitru is and what it is used for 
2. What you need to know before you use Cuvitru 
3. How to use Cuvitru 
4. Possible side effects 
5. How to store Cuvitru 
6. Contents of the packaging and other information 

1. What Cuvitru is and what it is used for

What Cuvitru is

Cuvitru belongs to a group of medicines called “human normal immunoglobulins”.

Immunoglobulins are also called antibodies and are found in the blood of healthy people. Antibodies are part of the immune system (the body’s natural defense system) and help the body fight infections.

How Cuvitru works

Cuvier is made from the blood of healthy people. The drug works in the same way as immunoglobulins that are found naturally in the blood.

What Cuvitru is used for

Cuvier is used in patients with weak immune systems, who do not have enough antibodies in their blood and often get infections. Regular and adequate doses of Cuvitru can raise the abnormally low levels of immunoglobulin in the blood to normal levels ( substitution therapy ).

Cuvier is prescribed to patients with the following conditions:

  • the impaired ability or inability to produce innate antibodies (primary immunodeficiency)
  • blood cancer ( chronic lymphocytic leukemia ) which produces low levels of antibodies in the blood and recurrent infection when prophylactic antibiotics can not be used
  • bone marrow cancer (multiple myeloma ) that provides low amounts of antibodies in the blood and recurrent infection s
  • low levels of antibodies in the blood after transplantation of bone marrow cells from another person.

2. What you need to know before using Cuvitru

DO NOT use Cuvitru:

  • if you are allergic to immunoglobulins or any of the other ingredients of this medicine (listed in section 6).
  • if you have an antibody to immunoglobulin A ( IgA ) in your blood. It can occur if you are deficient in IgA. Because Cuvitru contains trace amounts of IgA, you may have an allergic reaction.
  • Cuvitru should not be given into a blood vessel ( intravenously ) or a muscle ( intramuscularly ).

Warnings and cautions

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

If Cuvitru is stored in silicone-coated syringes for more than two hours, visible particles may form. The detailed instructions in “Method and route of administration” in section 3 of this leaflet must be followed carefully.

Allergic reactions

You may be allergic to immunoglobulins without knowing it. Allergic reactions such as a sudden drop in blood pressure or anaphylactic shock (severe drop in blood pressure in combination with other symptoms such as swelling of the airways, difficulty breathing, and rash) are rare, but they can sometimes occur even if you have not had problems with similar treatments before. 
The risk that you will get allergic reactions is higher if you have IgA deficiency with anti- IgA – antibody s. Tell your doctor or nurse before 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:

  • feeling drunk, dizzy, fainting
  • rash and itching, swelling of the mouth or throat, difficulty breathing, wheezing
  • abnormal heart rhythm, chest pain, blue lips, fingers or toes
  • blurred vision.

The first time you receive Cuvitru, the infusion is given slowly by a doctor or nurse, who monitors you so that any allergic reactions can be detected and treated immediately.

  • If you notice any of these signs during the infusions, tell your doctor or nurse immediately, who will decide whether to give the infusion more slowly or to stop it altogether.

Monitoring during infusion

Some side effects may be more common if:

  • you get Cuvitru for the first time.
  • you have received another immunoglobulin and switched to Cuvitru.
  • it’s been a long time since you last got the Cuvitru.
    • In these cases, you will be closely monitored during the first infusion and the first hour after the end of the infusion.

In all other cases, it is recommended that you be monitored during infusion one and for at least 20 minutes after the end of infusion one.

Special patient groups

Your doctor will be especially vigilant if you are overweight, have diabetes, high blood pressure, low blood volume ( hypovolemia ), or blood vessel problems (vascular disease). In these conditions, immunoglobulins may increase the risk of heart attack, stroke, pulmonary embolism, or deep vein thrombosis, but only in very rare cases.

Your doctor will also check if you have or have had kidney problems before or if you are receiving medicines that can damage your kidneys (nephrotoxic medicines) as there is a rare risk of acute kidney failure.

Meningitis (aseptic meningitis , AMS)

Infusion of immunoglobulin products can cause meningitis. Discontinuation of immunoglobulin therapy may reduce meningitis within a few days. Meningitis usually occurs a few hours up to 2 days after immunoglobulin treatment.

Contact your doctor if you experience the following symptoms: severe headache, stiff neck, drowsiness, fever, nausea, vomiting, and photosensitivity or discomfort of light after receiving Cuvitru.

The doctor will decide if more samples need to be taken and if treatment can continue.

Degradation of red blood cells ( hemolysis )

Cuvitru contains antibodies that can cause red blood cell breakdown and hemolytic anemia ( anemia ).

Effects on blood test analysis

Cuvitru contains several different antibodies and some of these may affect the results when the blood is analyzed (serological tests).

  • Talk to your doctor about your Cuvitru treatment before taking a blood test.


Treatment at home

You and/or your carer are trained to detect early signs of side effects, especially allergic reactions. During the infusion, you or your carer should be aware of the early signs of side effects are (further information in section 4, ” Possible side effects “).

  • If you experience any side effect is, you or your carer should immediately stop the infusion one and seek medical advice.
  • If you get a serious side effect, you or your caregiver should seek emergency help immediately.

Information about the original material in Cuvitru

Cuvier is made from human blood plasma (the liquid part of the blood). When medicines are made from human blood or plasma, certain measures are taken to prevent the transmission of infection to patients.

These include:

  • careful selection of blood and plasma donors to make sure those at risk of carrying the infection are excluded, and
  • testing of all individual donations and plasma pools to detect signs of viruses/infections.
  • measures in the processing of blood and plasma that can inactivate or completely remove viruses.

Nevertheless, the risk of transmission of infection can not be completely ruled out when drugs made from human blood or plasma are used. This also applies to unknown and new viruses or other types of infections.

The measures taken are considered effective for enveloped viruses, e.g. human immunodeficiency virus ( HIV ), hepatitis B virus, and hepatitis C virus, and for non-enveloped hepatitis A virus and parvovirus B19.

No correlation between immunoglobulins and noted infection s with hepatitis A virus parvovirus B19, which may be because the antibody is present in Cuvitru against this infectious s is protective.

The following information should be noted in the treatment diary, each time you receive a dose of Cuvitru:

  • date of injection one
  • batch number of the medicinal product and
  • the volume injected the flow rate, the number of injection sites, and its location.

Children and young people

The same warnings and precautions apply to both adults and children.

Other drugs and Cuvitru

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

Vaccinations

Cuvitru may reduce the effectiveness of some vaccines with viruses such as measles, rubella, mumps, and chickenpox (live virus vaccines). Once you have received Cuvitru, you may have to wait up to 3 months before receiving certain vaccines. You may have to wait up to 1 year after receiving the last dose of Cuvitru before you can get the measles vaccine.

  • Tell your vaccinating doctor or nurse about your treatment with Cuvitru.

Pregnancy, breastfeeding, and fertility

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.

No clinical trials have been performed with Cuvitru in pregnant or lactating women. However, experience with immunoglobulins suggests that no harmful effects are expected during pregnancy or in the infant.

If you are breast-feeding and receiving Cuvitru, the antibodies from the medicine will also be present in your breast milk and may protect your baby from certain infections.

Experience with immunoglobulins shows that there are no expected detrimental effects on fertility.

Driving and using machines

Patients may experience side effects (such as dizziness or nausea) during treatment with Cuvitru that may affect their ability to drive and use machines. If this happens, wait until the reactions have passed.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

3. How to use Cuvitru

Always use this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.

Cuvitru must be given under the skin ( subcutaneous administration ).

Cuvitru treatment is started by a doctor or nurse, but you can use the medicine at home once you have received the first infusions under medical supervision and you (and/or your carer) have received appropriate training. You and your doctor will decide if you can use Cuvitru at home. Do not start treatment with Cuvitru at home until you have received complete instructions.

Dosage

Your doctor will calculate the correct dose for you, based on your body weight, any previous treatment, and how you respond to the treatment.

Your doctor will decide if you need a loading dose (for adults or children) of at least 1.0 to 2.5 ml/kg bodyweight spread over several days. After this, you will receive Cuvitru regularly, from daily to once every two weeks. The total dose one per month will be about 1.5 to 5 ml/kg body weight. Your doctor may adjust your dose depending on how you respond to treatment.

Do not change the dose or dosing interval without consulting your doctor. If you think you should get Cuvitru more often or less often, talk to your doctor. If you think you have missed a dose, talk to your doctor as soon as possible.

Start treatment

Your treatment is started by a doctor or nurse who has experience in treating patients with weak immune systems and instructing patients for treatment at home. You will be closely monitored throughout infusion one and for at least 1 hour after the end of infusion one to see how well you tolerate the medicine.

Initially, the doctor or nurse uses a slow infusion rate and gradually increases it during the first infusion and subsequent infusions. Once the doctor or nurse has arrived at the right dose and infusion rate for you, you can give the treatment to yourself at home.

Treatment at home

You or your carer can administer Cuvitru on their own. You will be trained by a doctor or nurse who has experience in instructing and treating patients in your situation. The doctor or nurse will be with you during the first treatments.

You or your carer will be instructed in:

  • bacteria-free (aseptic) infusion technique,
  • how to use an injection/infusion pump (if needed),
  • how to keep treatment diary,
  • measures in case of serious side effects.

You must follow the doctor’s instructions regarding the dose, infusion rate, and the frequency of infusion of Cuvitru so that the treatment will work for you.

Method of administration and route of administration

Choice of infusion site (s): 

The following sites are recommended for subcutaneous infusion of Cuvitru: abdomen, thighs, upper arms, and lumbar spine. Cuvitru can be infused at several infusion sites. The infusion sites should be at least 10 cm apart.

Avoid bony areas, visible blood vessels, scars, and areas that may be inflamed (irritated) or infected.

Switch between different places for each administration according to the instructions given to you by your doctor or nurse.

Multiple subcutaneous infusion sites can be used simultaneously with a set of multiple needles. The amount of medicine given depends on the infusion site and doses over 30 ml can be divided into several infusion sites.

Infusion rate: 

The recommended initial infusion rate is 10 ml per hour per infusion site. If well tolerated, it can be increased at intervals of at least 10 minutes to 20 ml per hour per site for the first two infusions. For subsequent infusions, the infusion rate may be increased as tolerated.

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

Detailed instructions for use can be found in the section below:

Do not use Cuvitru at home until you have received instructions and training from your doctor or nurse.

Prepare the Cuvitru bottle (s):

  • Take the Cuvitru out of the box. If the product is stored in a refrigerator, allow the bottle (s) to reach room temperature. It can take up to 90 minutes.
  • The bottle (s) should not be heated further, not even in the microwave.
  • Do not shake the bottle (s).
1. Check the bottle (s): Expiration date; may not be used after the expiry date. Protective cap; must not be used if the protective cover is missing or damaged. Look at the color: it should be clear and colorless to pale yellow or light brown. Do not use the solution if it is cloudy or contains particles.
2. Bring all accessories to bring out all accessories: This is needed: bottle/bottles with Cuvitru, infusion accessory: subcutaneous needle set, transfer device (s) (aerated spike), syringe/syringes, sterile needle guard, sterile clear bandage, tape, gauze, a container for puncturing and cutting objects, infusion pump, treatment diary. Clean the work surface. Program the infusion pump according to the prescribed infusion rates and the manufacturer’s instructions. Wash your hands thoroughly and let them dry. Open the accessory as shown by your doctor or nurse.
3. Prepare the syringe (s): Remove the cap from the bottle. Wipe the stopper with a sterile alcohol swab and allow it to dry. Connect a sterile syringe to an aerated spike. Insert the aerated nail in the center of the bottle. Turn the bottle upside down and pull back the syringe plunger to draw the solution into the syringe. Repeat these steps if you use multiple bottles to achieve the desired dose. Infusion must be started immediately after transferring Cuvitru to the syringe. If the administration is expected to take more than two hours, the required dose should be divided and administered at different infusion sites. If Cuvitru is stored in silicone-coated syringes for more than two hours, visible particles may form. When using a sterile needle: Connect a sterile syringe to the sterile needle and retract the syringe plunger to fill the syringe with as much air as the amount of solution you will take from the bottle. Insert the needle in the center of the stopper and inject the air. Pull back the syringe plunger to pull out the desired volume.
4. Prepare the infusion pump and tubing: Fill the hose and use the pump according to the manufacturer’s instructions connect the syringe filled with the solution to the needle set. Let the syringe tip point upwards and gently push in the syringe plunger to remove the air and fill the needle set up to the wings of the needle.
5. Prepare the infusion site (s): Select the number of infusion sites based on the volume of the total dose . Choose infusion site (s): 
upper arms, abdomen, thighs, or lumbar spite avoid bony areas, visible blood vessels, scars, and any areas that are inflamed (irritated) or infected. Infuse the solution in 1 or more infusion sites simultaneously. Choose places that are at least 10 cm apart. Switch between different places for later infusions. Wipe the infusion site with a sterile alcohol swab, starting in the center of the infusion site and wiping out in a circular motion. Allow the infusion site to dry (for at least 30 seconds).
6. Insert and secure the subcutaneous needle set: Remove the needle cover. Use two fingers and take a firm grip on the skin so that you get at least 2.5 cm between the fingers. Insert the needle with a quick motion, straight into the skin at a 90-degree angle. Tape the needle in place with sterile tape (found on the clear bandage). Repeat the above if more than one place is used. Secure the needle set in place by placing a sterile protective dressing over the stand (s).
7. Start infusion follow the manufacturer’s instructions on how to start the pump and start the infusion. Check the infusion sites from time to time throughout the infusion.
8. Remove the needle from the infusion site when the infusion is complete: Remove the needle set by loosening the tape at all edges. Pull the needle wings straight up. Gently press with a small piece of compress over the injection site and cover with a bandage. Discard all needles in a stinging and cutting waste container.
9. Record infusion one in the treatment diary: Remove the removable label that contains the product’s batch number and expiration date from the bottle (s) and attach the label to your treatment diary. Record the date, time, dose, infusion site (s) (to help you change sites) and any reactions after each infusion. Dispose of disposable items, bottles, and unused solutions as directed by your physician or nurse.

Use for children and adolescents

The same indications, dose, and frequency of infusion as for adults apply to children and adolescents (0 to 18 years).

If you use more Cuvitru then you should 

If you think you have used too much Cuvitru, talk to your doctor as soon as possible. If e.g. a child ingested the medicine accidentally contact a doctor, hospital, or the Poison Information Center for assessment of the risk and advice.

If you forget to use Cuvitru

Do not take a double dose of Cuvitru to make up for a forgotten dose. If you think you have missed a dose, talk to your doctor as soon as possible.

4. Possible side effects

Like all medicines, this medicine can cause side effects, such as chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, joint pain, low blood pressure, and moderate low back or lower back pain, but not all users need them.

Some side effects such as headaches, chills, and body aches can be reduced by lowering the infusion rate.

Serious side effects are

Infusion of drugs such as Cuvitru can sometimes lead to serious, but rare, allergic reactions. You may experience a sudden drop in blood pressure and some cases anaphylactic shock. Your doctor will be aware of these possible side effects and will monitor you during and after the initial infusions.

Tell your doctor or nurse immediately if you experience any of the following:

  • intoxication, dizziness, fainting,
  • rash and itching, swelling of the mouth or throat, difficulty breathing, wheezing,
  • abnormal heart rhythm, chest pain, blue lips, fingers or toes,
  • blurred vision.

When you use Cuvitru at home, you can perform infusion one in the presence of your caregiver to help you detect allergic reactions, discontinue the infusion one, and get help if needed.

See also section 2 of this leaflet for the risk of allergic reactions and the use of Cuvitru in the home.

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

  • headache
  • diarrhea and nausea
  • redness and pain at the infusion site
  • fatigue

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
  • muscle aches
  • swelling, itching, rash, and bruising at the injection site
  • pain

The following side effects are uncommon (may affect more than 1 in 1,000 people):

  • burning sensation
  • lower abdominal pain
  • edema at the infusion site
  • positive test results of blood samples for antibody s

Side effects are observed with similar drugs

The following side effects have been observed withan infusion of human normal immunoglobulin given subcutaneously. Although these side effects have not been observed with Cuvitru to date, someone using Cuvitru may get them.

  • irritations
  • tremors
  • fast heartbeat
  • shortness of breath
  • disturbed mobility of the vocal cords
  • chest pain
  • hardening and/or feeling of warmth at the infusion site

5. How to store Cuvitru

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 label and carton after EXP. The expiration date is the last day of the specified month.

Do not use this medicine if you notice that the solution is cloudy, contains particles, or has changed color.

Store the bottles in the outer carton. Sensitive to light.

Do not store above 25 ° C.

Do not freeze.

If the product is stored in a refrigerator, the unopened bottles must be removed from the refrigerator and placed at room temperature for at least 90 minutes before use. Do not use heaters or microwave ovens.

6. Contents of the packaging and other information

Content declaration

The active substance is human normal immunoglobulin.

  • 1 ml of Cuvitru contains 200 mg of human protein of which at least 98% is immunoglobulin G (IgG).
  • The other ingredients are glycine and water for injections.

What the medicine looks like and the contents of the pack

Cuvier is an injection solution in vials of 5, 10, 20, 40 or

50 ml. The solution is clear and colorless or pale yellow or light brown.

1 vial of 5 ml contains 1 g of human normal immunoglobulin

1 vial of 10 ml contains 2 g of human normal immunoglobulin

1 vial of 20 ml contains 4 g of human normal immunoglobulin

1 vial of 40 ml contains 8 g of human normal immunoglobulin

1 vial of 50 ml contains 10 g of human normal immunoglobulin

Pack sizes:

1 vial, 10 or 20 vials with 5 ml solution for injection

1 vial, 10, 20, or 30 vials with 10 ml solution for injection

1 vial, 10, 20, or 30 vials with 20 ml solution for injection

1 vial, 5, 10, or 20 vials with 40 ml solution for injection

1 vial with 50 ml solution for injection

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Baxalta Innovations GmbH

Industriestrasse 67

A ‑ 1221 Vienna

Austria

Manufacturer

Baxalta Belgium Manufacturing SA

Boulevard René Branquart 80

7860 Lessines

Belgium

Local representative

Takeda Pharma AB

Vasagatan 7, 6 tr

111 20 Stockholm

Muhammad Nadeem

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