200 mg/ml solution for
injection for subcutaneous injection
Human normal immunoglobulin (SCIg)
What Xembify is and what it is used for
What Xembify is
Xembify is a solution with human immunoglobulins ( antibodies, mainly immunoglobulin G) that help the body fight infection.
Xembify contains immunoglobulins extracted from the plasma of healthy people. Immunoglobulins help fight infection caused by bacteria and viruses. The medicine works in the same way as the immunoglobulins produced by the immune system and found naturally in the blood.
What Xembify is used for
You are using Xembify because you have abnormally low levels of immunoglobulins due to a disease called immunodeficiency. Infusion with Xembify raises the levels of immunoglobulin ( antibodies ) in the blood to normal levels, especially immunoglobulin G (IgG).
This medicine is for adults, children, and adolescents (0–18 years) who do not have enough antibodies ( substitution therapy ).
- Patients with primary immunodeficiency syndromes (PID) who are congenitally deficient in antibody ar.
- Hypogammaglobulinemia (a disease that causes low levels of immunoglobulin in the blood) and recurrent bacterial infections in patients with chronic lymphocytic leukemia (blood cancer that causes the body to make too many white blood cells ), when preventive treatment with antibiotics has failed.
- Hypogammaglobulinemia and recurrent bacterial infections in patients with multiple myeloma ( a tumor composed of cells from the bone marrow ).
- Hypogammaglobulinemia in patients after stem cell transplantation ( allogeneic hematopoietic stem cell transplantation, HSCT ), is when you receive stem cells from another person.
Human normal immunoglobulin (SCIg) contained in Xembify may also be approved to treat other conditions not mentioned in this product information. Ask a doctor, pharmacist, or another healthcare professional if you have further questions, and always follow their instructions.
What you need to know before using Xembify
Do not use Xembify
- if you are allergic to human normal immunoglobulin or any of the other ingredients of this medicine (listed in section 6)
- if you have had a severe allergic reaction (such as anaphylactic shock ) to a human immunoglobulin
- if you have antibodies against immunoglobulin A ( IgA ) in your blood. This can occur if you are deficient in IgA. Because Xembify contains IgA, you may have an allergic reaction.
- by injecting it into a blood vessel ( intravenously ) or a muscle ( intramuscularly ).
If you have had side effects from an immunoglobulin or any of the other ingredients, you must tell your doctor, pharmacist, or nurse before receiving Xembify.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Xembify.
- Tell the doctor if you have or have had heart or blood vessel disease, blood clots (such as a stroke, heart attack, or pulmonary embolism ), thick blood, diabetes mellitus, high blood pressure, bleeding or clotting disorder, or if you have been immobile during a longer period. Tell the doctor if you take estrogen, usually as a contraceptive. You may be at greater risk of developing a blood clot after infusing Xembify. Contact a doctor immediately if you experience shortness of breath; chest pains; pain and swelling in an arm or leg, or weakness or numbness on one side of the body. You may have had a blood clot.
- Contact a doctor if you experience severe headache, stiff neck, drowsiness, fever, extreme sensitivity to light, nausea, or vomiting. These side effects can occur several hours or even several days after the infusion of Xembify. You may have contracted meningitis (aseptic meningitis ).
- Xembify can cause kidney problems, including kidney failure. Tell the doctor if you have impaired kidney function.
- Xembify can affect certain blood tests (serological tests). Always tell the doctor that you are being treated with Xembify before having any blood tests.
Allergic reactions
Allergic reactions are rare. However, 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 combined with other symptoms such as swelling of the throat, difficulty breathing, and skin rash) are rare, but can sometimes occur even if you have not had side effects from immunoglobulins before. The risk of allergic reactions is greater if you have an IgA deficiency with anti – IgA antibodies. If you have IgA deficiency, you must tell your doctor. Xembify contains a certain amount of IgA, which may increase the risk of an allergic reaction. Information on signs and symptoms of an allergic reaction can be found in section 4 of this leaflet (Possible side effects ).
Risk of disease transmission
Xembify is purified from human plasma that comes from healthy donors. When biological medicines are given, the risk of infectious diseases being transmitted through disease-causing organisms cannot be completely ruled out. However, for drugs produced from human plasma, the risk of transmission of disease-causing organisms is reduced by: (1) screening of donors; selection of donors through a medical interview; (2) testing individual donations and plasma pools for evidence of viral infections; and (3) manufacturing measures proven to inactivate/remove disease-causing organisms.
Despite these measures, the risk of transmission of infection when medicines made from human blood or plasma are administered cannot be completely ruled out. This also applies to unknown and new viruses or other types of infection.
The measures taken are considered effective against enveloped viruses such as human immunodeficiency virus ( HIV ), hepatitis B virus, and hepatitis C virus as well as for non-enveloped hepatitis A viruses. The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19.
Immunoglobulins have not been associated with infection with hepatitis A virus or parvovirus B19, possibly because the antibodies contained in the medicine have a protective effect.
It is strongly recommended that the name of the medicinal product and the batch number (listed on the label and carton after the Lot) be recorded each time Xembify is given so that there is a record of batches used.
Children and young people
The section “Warnings and precautions” applies to adults, children, and adolescents.
Other medicines and Xembify
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Always take Xembify separately and do not mix it with any other medicine.
If you are to be vaccinated, tell the doctor that you are being treated with Xembify. Xembify can impair the effectiveness of certain vaccines (live virus vaccines) such as measles, mumps, rubella, and chicken pox vaccines. You may have to wait up to 3 months after receiving Xembify to get vaccinated. You may have to wait up to 1 year for the measles vaccine.
This impact on vaccines applies to children, adults, and the elderly.
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 or pharmacist for advice before using this medicine.
Xembify has not been studied in pregnant or breastfeeding women, so your doctor or pharmacist will guide you. Experience from the use of immunoglobulin er does not indicate any harmful effects during pregnancy, on the fetus, or the child. If you are breastfeeding, the immunoglobulins in Xembify may also be present in your breast milk. These can protect your child against certain infections. Clinical experience with immunoglobulins shows that no harmful effects on fertility are expected.
Driving ability and use of machinery
The ability to drive and use machines may be impaired due to specific side effects that Xembify can cause, such as dizziness. If you experience side effects during treatment, you must wait until these have passed before driving or using machinery.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased 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. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
How to use Xembify
Always use this medicine as directed by your doctor. Consult a doctor if you are unsure.
Xembify must be infused under the skin ( subcutaneous administration ).
Treatment with Xembify is started by a doctor or nurse. Do not start treatment with Xembify at home until you have received full instructions.
Dose
Recommended dose and dosage schedule are determined by the doctor. The doctor calculates the right dose for you based on your body weight, any previous treatment you may have received, and how you respond to treatment. Always use this medicine as described in this leaflet or as directed by your doctor, pharmacist, or nurse. Consult them if you are unsure.
Your first dose may be a so-called “loading dose”, which is intended to quickly increase the levels of immunoglobulin in the blood. The doctor will decide if you need a “loading dose” (for adults and children) of at least 1 to 2.5 ml/kg body weight. You can get this loading dose divided over several days.
You receive Xembify regularly from daily to once every two weeks. The total dose once per month is approximately 1.5 to 5 ml/kg body weight. The doctor may adjust the dose depending on how you respond to the treatment.
Do not change dose one or the time interval to the next dose without first talking to your doctor.
If you think you need a different dose or want to change your dosing schedule, you must first talk to your doctor. Contact your doctor if you miss a dose.
Routine blood tests will be taken to measure the level of immunoglobulin in your blood. Discuss the schedule with your doctor.
There is no difference in dosage for adults, including the elderly (65 years and older), children, or infants because the amount of Xembify is based on body weight.
Mode of administration
You receive Xembify by a slow infusion under the skin into fatty tissue ( subcutaneous infusion ). Xembify is given via a pump or injector. Subcutaneous infusion for home treatment should be initiated and supervised by healthcare professionals experienced in instructing patients in-home treatment.
You (or your carer) must be instructed in:
- how to use the administration equipment, such as a syringe pump, if needed
- aseptic (bacteria-free) infusion techniques,
- how to keep a treatment diary and
- how to recognize serious side effects and what measures should be taken if such occur.
For the treatment to work, you must follow the doctor’s instructions carefully regarding the dose, infusion rate, and schedule of infusion of Xembify.
Infusion sites
Xembify is intended for subcutaneous infusion only. Infuse Xembify into subcutaneous tissue in eg
- the stomach
- the thighs
- the upper arms and
- side of the hip
When choosing an infusion site, avoid bony areas, visible blood vessels, scars, and any areas that are inflamed (irritated) or infected. Change the infusion site between each infusion.
For the first two infusions, the infusion rate starts at 10 ml per hour per infusion site. If you do not experience any side effects (see section 4), the rate can be increased every 10 minutes to a maximum of 20 ml per hour per infusion site for children and adolescents, and 25 ml per hour per infusion site for adults. After two rounds of infusion, the dose rate can be gradually increased to 35 ml per hour and the infusion site. Talk to your doctor before increasing the infusion rate.
You can give an infusion in more than one place at the same time as long as there is at least a 5 cm distance between the infusion sites. Adults can divide the dose into several places, especially if the volume is greater than 30 ml. There is no limit to the number of places you can use. You can use more than one pump to do this.
Instructions for use
Subcutaneous infusion for home treatment should be initiated and supervised by healthcare professionals experienced in instructing patients in-home treatment. Infusion pumps suitable for subcutaneous administration of immunoglobulins can be used. The patient or a carer must be given instructions on how to use an infusion pump, on infusion techniques, how to keep a treatment diary, and how to identify serious side effects, and what measures to take.
Follow the steps below and use the aseptic technique to administer Xembify.
Allow the solution to reach room or body temperature (20–37 °C) before use. It may take 60 minutes or longer.
Do not apply heat or use a microwave oven.
Step 1: Gather the materials
Obtain the Xembify vial(s), accessories, sharps and sharps container, treatment diary/logbook, and infusion pump(s).
Step 2: Clean the surface
Prepare a site for infusion on a clean, flat, non-porous surface, such as a kitchen counter.
Avoid porous surfaces such as wood. Clean the surface with an alcohol-moistened compress in circular motions from the center outwards.
Step 3: Wash your hands
Wash and dry your hands thoroughly before using Xembify.
The health care professional may recommend that you use antibacterial soap or gloves.
Step 4: Check the vials
The liquid in the bottle should be clear to slightly opalescent and colorless or slightly yellow or light brown.
Do not use the bottle if:
- The solution is cloudy or discolored. The solution should be clear to slightly opalescent and colorless or slightly yellow or light brown.
- The protective cap is missing or there are signs that the seal has been broken. Inform medical personnel immediately.
- The expiration date has passed.
Step 5: Remove the protective cover
Remove the protective cap from the vial so that the center of the vial stopper is visible.
Wipe the bottle cap with alcohol and let it dry.
Step 6: Transfer Xembify from the vial(s) to the syringe
Make sure that fingers or other objects do not touch the plunger shaft, the syringe tip, or other areas that may come into contact with the Xembify solution. Make sure all needles have needle covers on until they are used and that needles and syringes remain in the clean area you prepared in step 2 at all times. This is called the “aseptic technique” and prevents bacteria from getting into the Xembify solution.
Attach the needle to the syringe tip using an aseptic technique.
Step 7: Prepare the syringe and draw Xembify solution into the syringe
Remove the needle cover.
Pull back the syringe plunger to the level corresponding to the amount of Xembify to be withdrawn from the vial.
Place the vial on a clean, flat surface and insert the needle into the center of the vial stopper.
Inject air into the vial. The amount of air should be equal to the amount of Xembify that needs to be drawn up.
Turn the vial upside down and withdraw the correct amount of Xembify. If several vials are needed to get the correct dose, repeat steps 4-7.
Use the solution immediately after transferring Xembify from the vial to the syringe.
Step 8: Prepare the infusion pump
Follow the pump manufacturer’s instructions on how to prepare the infusion pump, administration tubing, and Y-connect tubing, if necessary.
Fill the administration tube with Xembify to remove any air remaining in the box or needle. To fill the box, hold the syringe in one hand and the administration tube needle, with the needle cover on, in the other hand. Gently press the plunger until you see a drop of Xembify come out of the needle.
Step 9: Select the number and location of the infusion sites
Select one or more infusion sites as directed by the healthcare professional.
It is the volume of the total dose that determines the number of infusion sites and their location.
Suitable infusion sites are the abdomen, thighs, upper arms, and side of the hip.
Avoid bony areas, visible blood vessels, scars, and any areas that are inflamed (irritated) or infected.
Change the infusion site between each infusion.
Step 10: Prepare the infusion site
Wipe the infusion site(s) with a sterile alcohol-moistened pad in circular motions from the center outwards. Allow the infusion site(s) to dry (for at least 30 seconds).
Before starting the infusion, the injection sites must be clean, dry, and at least 5 cm apart.
Step 11: Insert the needle
Grasp the skin with two fingers (make sure to leave at least 2.5 cm between the fingers). Insert the needle into the tissue under the skin ( subcutaneous tissue ) at a 90-degree angle.
Step 12: Make sure the needle is not in a blood vessel
After inserting the needle into tissue one (and before infusing one), you must ensure that you have not accidentally hit a blood vessel. To do this, you connect a sterile syringe to the filled administration stroke. Pull back on the syringe plunger and see if blood is drawn into the administration tube.
If you see blood, remove and discard the needle and administration tube.
Repeat the steps to prime the tubing and insert the needle with a new needle, administration tubing, and a new infusion site.
Secure the needle by placing a sterile gauze pad or sterile transparent dressing over the needle.
Step 13: Repeat for other locations, as needed
Step 14: Infuse Xembify
Infuse Xembify as soon as possible after preparing the solution.
Follow the manufacturer’s instructions for filling the tubing and using the infusion pump.
Step 15: After infusion a
Follow the manufacturer’s instructions on how to turn off the pump.
Remove and discard any dressings or tape.
Carefully remove the inserted needles.
Dispose of any unused solution in an appropriate waste container as directed.
Dispose of any used equipment in a suitable waste container.
Store the material in a safe place.
Follow the manufacturer’s instructions for the care of the syringe pump.
Step 16: Record each infusion
Peel the peel-off label with the medicinal product batch number from the vial and use the label to complete the treatment diary. Include information about each infusion such as:
- time and date
- dose
- manufacturing batch number (lot number)
- infusion site and
- possible side effects
Don’t forget to take the diary with you when you go to the doctor’s appointment. The doctor may ask to see your treatment diary/log book.
Tell the doctor if you experience problems during the infusions. Call a healthcare professional for medical advice about side effects.
Use for children and adolescents
In infants and children, the infusion site may be changed every 5 to 15 mL.
If you have used too much Xembify
If you have ingested too much medicine or if, for example, If a child has ingested the medicine by mistake, immediately contact a doctor or hospital for an assessment of the risk and advice.
If you forgot to use Xembify
Do not take a double dose to make up for a missed dose. Contact your doctor for instructions.
If you stop using Xembify
If you have any further questions about this medicine, ask your doctor.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
In rare cases, human normal immunoglobulins can cause a sudden drop in blood pressure and anaphylactic shock, even if the patient has not shown signs of hypersensitivity upon previous administration.
Signs or symptoms of these rare allergic reactions are:
- dizziness or feeling faint
- skin rash and itching, swelling of the mouth or throat, difficulty breathing, wheezing
- abnormal heart rhythm, chest pain, blue lips, fingers, or toes.
If you notice any signs of an allergic reaction or anaphylactic shock during the infusion of Xembify, stop the infusion immediately and contact your doctor or go to the nearest hospital. See section 2 of this leaflet (Warnings and precautions). If you notice any of these signs during the infusion of Xembify when given by a healthcare professional, tell the doctor or nurse immediately. He or she decides whether the infusion rate should be reduced or whether the infusion should be stopped completely.
Local reactions may occur at the infusion site, such as swelling, tenderness, redness, induration, local warmth, itching, bruising, and rash.
Xembify can occasionally cause chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, joint pain, low blood pressure, and moderate pain in the lower back.
The following side effect is very common with Xembify (may affect more than 1 in 10 people):
- Local reaction at the infusion site
The following side effects are common with Xembify (may affect more than 1 in 100 people):
- Headache
- Joint pain
- Back pain
- Runny nose, sneezing, and nasal congestion ( rhinitis )
- Diarrhea
- Nausea
- Fever
- Decreased level of immunoglobulin G in the blood
- Itching
- Small raised areas of skin ( papules )
Adverse event reporting after marketing approval
The following side effects have been identified and reported in post-marketing use of Xembify (all non-serious): shortness of breath ( dyspnoea ), fatigue, pain, nausea, headache, and local reaction at the infusion site such as redness ( erythema ) and swelling. It is not always possible to estimate the frequency of these reactions reliably.
How Xembify should be stored
Keep this medicine out of the sight and reach of children.
- Store in a refrigerator (2 ºC–8 ºC).
- Xembify can be stored at temperatures not exceeding 25 °C for up to 6 months before the expiry date.
- When the medicine is taken out of the refrigerator, either the date 6 months from the current date or the expiry date printed on the carton tab should be written in the “Discard date” box on the carton, whichever occurs first.
- If the medicine has been stored at room temperature, it should not be put back in the refrigerator. Use the medicine before the discard date or discard it.
- Do not freeze.
- Store the vial in the outer carton. Light sensitive.
- Administer as soon as possible after transferring Xembify from the vial to a syringe.
Use before the expiry date stated on the label and carton.
Do not use this medicine if you notice it is discolored, cloudy has deposited, or if has been frozen.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
What Xembify contains
- The active substance is human normal immunoglobulin (SCIg). 1 ml contains 200 mg of human normal immunoglobulin, of which at least 98% is IgG. The percentage of IgG subclasses is approximately 62% IgG 1, 30% IgG 2, 4.3% IgG 3, and 3.2% IgG 4. It contains a certain amount of IgA (not more than 160 micrograms/ml.).
- Other ingredients are glycine (E640), polysorbate 80 (E433), and water for injections.
Appearance and package sizes of the medicine
Xembify is a solution for injection for subcutaneous injection. The solution is clear to slightly opalescent and colorless or slightly yellow or light brown.
Xembify is packaged in a carton containing a clear glass bottle with a stopper, aluminum seal, plastic top, and shrink seal to ensure the package is intact.
Xembify is supplied in the following pack sizes:
5 ml = 1 g
10ml = 2g
20 ml = 4 g
50ml = 10g
A carton contains a vial of Xembify and a package leaflet.
Instituto Grifols, SA
Can Guasc, 2 – Parets del Vallès
08150 Barcelona – Spain