100 mg/ml solution for infusion for subcutaneous use in
human normal immunoglobulin
1. What HyQvia is and what it is used for
What HyQvia is
HyQvia contains two solutions for infusion (drip) under the skin ( subcutaneous or sc infusion ). It is supplied as a pack containing a vial of human normal immunoglobulin 10% (the active substance) and a vial of recombinant human hyaluronidase (a substance that helps human normal immunoglobulin 10% to enter the bloodstream).
Human normal immunoglobulin 10% belong 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 HyQvia works
The vial of immunoglobulins has been prepared from the blood of healthy people. The drug works in exactly the same way as immunoglobulins that are found naturally in the blood. Recombinant human hyaluronidase is a protein that makes it easier for immunoglobulins to be infused (given as a drip) under the skin and into the bloodstream.
What HyQvia is used for
HyQvia is used in patients with weak immune systems, who do not have enough antibodies in their blood and often suffer from infections. Regular and adequate doses of HyQvia can raise the abnormally low levels of immunoglobulin in the blood to normal levels ( substitution therapy ).
HyQvia is prescribed as replacement therapy for patients who do not have enough antibodies, which includes the following groups:
- patients with congenital incapacity or impaired ability to produce antibodies (primary immunodeficiency disease).
- Patients who experience severe or recurrent infection due to a weakened immune system caused by other conditions or treatments.
2. What you need to know before using HyQvia
HyQvia must not be injected or infused
- if you are allergic to immunoglobulins, hyaluronidase, recombinant hyaluronidase or any of the other ingredients of this medicine (see section 6, “Contents of the pack and other information”)
- if you have an antibody to immunoglobulin A ( IgA ) in your blood. This can happen if you are deficient in IgA . Because HyQvia contains trace amounts of IgA , you may have an allergic reaction .
- in a blood vessel ( intravenously ).
Warnings and cautions
The following warnings and precautions should be considered before receiving or using HyQvia. If you have any questions, talk to your doctor or nurse.
Pregnancy, breastfeeding and fertility
The effects of long-term use of recombinant human hyaluronidase on pregnancy, lactation, and fertility are currently unknown.
HyQvia should only be used by pregnant or lactating women after consultation with your doctor. If you become pregnant while using HyQvia, you should also discuss with your doctor the possibility of participating in a pregnancy registry to collect data on your pregnancy and your baby’s development. The purpose of such a register is to collect and share data only with the public health authorities responsible for the safety of this product. Participation in this register is voluntary.
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 combined 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 of getting allergic reactions is higher if you have IgA deficiency with anti-IgA antibodies. Signs or symptoms of these rare allergic reactions include:
- 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.
First, a doctor or nurse infuses HyQvia slowly and monitors you during the first infusions 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. He or she decides whether the infusion rate should be slowed down or whether the infusion should be stopped altogether.
Infusion rate
It is very important to infuse the drug at the right rate. Your doctor or nurse will advise you on the appropriate infusion rate when infusing HyQvia at home (see section 3, “ How to use HyQvia ”).
Monitoring during infusion
Some side effects may be more common if:
- you get HyQvia for the first time.
- you have received another immunoglobulin and have switched to HyQvia.
- it has been a long interval (eg more than 2 or 3 infusion intervals) since you last received HyQvia.
- In such cases, you will be closely monitored during the first infusion and during the first hour after the end of the infusion .
In all other cases, you should be monitored during infusion one and for at least 20 minutes after receiving HyQvia during the first infusions.
Treatment at home
Before starting treatment at home, appoint a supervisor. You and your supervisor are trained to detect early signs of side effects, especially allergic reactions. The supervisor should help you keep track of any side effects. During infusion, the need to be alert to the early signs of side effects are (further information in section 4, ” Possible side effects”).
- If you experience any side effects , you or your supervisor should stop the infusion immediately and contact a doctor.
- If you experience a serious side effect , you or your supervisor should seek emergency help immediately .
Spread of local infection er
Do not infuse HyQvia in or around an infected or red and swollen area of the skin as it may spread the infection.
No long-term ( chronic ) changes in the skin have been observed in clinical trials. All prolonged inflammation, lumps (nodules), or inflammation that occurs at the infusion site and lasts for more than a few days should be reported to a doctor.
Effects on blood tests
HyQvia contains several different antibodies and some of these may affect blood tests (serological tests).
- Talk to your doctor about your treatment with HyQvia before taking a blood test.
Information about the source material in HyQvia
Human normal immunoglobulin 10% in HyQvia and human serum albumin (an ingredient in recombinant human hyaluronidase) are produced from human plasma (the liquid part of the blood). When medicines are made from human blood or human plasma, certain measures are taken to prevent the spread of infection to patients. These include:
- careful selection of blood and plasma donors to ensure that those at risk of infection are excluded, and
- testing of all donations and plasma pools to detect signs of viruses / infections.
Even during the manufacture of these products, measures are taken in blood or plasma processing that can inactivate or eliminate viruses. Nevertheless, the risk of transmission of infection can not be completely ruled out when drugs made from human blood or human plasma are used. This also applies to unknown and new viruses or other types of infection.
The measures taken in the manufacture of HyQvia are considered to be 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.
Immunoglobulins have not been associated with infections with hepatitis A virus or parvovirus B19, possibly because the antibody is against these infectious s contained in HyQvia is protective.
It is recommended that the following information be noted in the treatment diary each time you receive a dose of HyQvia:
- the date of administration
- the batch number of the medicinal product and
- the volume injected, the flow rate, the number of infusion sites and their location.
Children and young people
The same indications, dose, and frequency of infusion as for adults apply to children and adolescents (0-18 years).
Other medicines and HyQvia
Tell your doctor, pharmacist, or nurse if you have recently taken or might take any other medicines.
Vaccinations
HyQvia can reduce the effects of certain viral vaccines such as measles, rubella, mumps, and chickenpox (live virus vaccines). Once you have received HyQvia, you may have to wait up to 3 months before receiving certain vaccines. You may have to wait up to 1 year after receiving HyQvia before you can get the measles vaccine.
- Talk to your vaccination doctor or nurse about your treatment with HyQvia.
Driving and using machines
Patients may experience side effects (such as dizziness or nausea) during treatment with HyQvia that may affect their ability to drive and use machines. If this happens, wait until the reactions have passed.
HyQvia contains sodium
This medicine contains 5.0-60.5 mg sodium (the main ingredient in table salt/table salt) per vial of HyQvia recombinant human hyaluronidase. This corresponds to 0.25–3% of the highest recommended daily intake of sodium for adults. The IG 10% component is almost “sodium-free”.
3. How to use HyQvia
Always use this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.
HyQvia must be infused under the skin ( subcutaneous or sc administration ).
Treatment with HyQvia 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 supervisor) have received appropriate training. You and your doctor will decide if you can use HyQvia at home. Do not start treatment with HyQvia 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 you may have received, and how you are responding to the treatment. The recommended starting dose is 400 to 800 mg of active substance per kg body weight per month. Initially, you will receive a quarter of this dose at 1-week intervals. The dose is gradually increased to larger doses over 3 to 4-week intervals during the following infusions. Sometimes the doctor may recommend that large doses be divided and given in two places at the same time. Your doctor may also adjust your dose depending on how you respond to treatment.
Start treatment
Your treatment is started by a doctor or nurse who has experience in treating patients with weak immune systems and instructing patients on in-home treatment. You will be closely monitored throughout the infusion one and for at least 1 hour after the infusion one has been stopped 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 during 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 will be instructed in:
- Bacteria-free (aseptic) infusion techniques
- How to use an infusion pump or syringe pump (if needed)
- How to keep treatment diary
- Measures to be taken in case of serious side effects .
You must follow your doctor’s instructions carefully regarding the dose, infusion rate, and schedule of infusion of HyQvia so that the treatment works for you.
| Patients <40 kg | Patients ≥ 40 kg | |||
| Interval / minutes | First two infusions (ml / hour / infusion site) | The following 2‑3 infusions (ml / hour / infusion site) | The first two infusion engines (ml / h / infusion site) | The following 2‑3 infusions (ml / hour / infusion site) |
| 10 minutes | 5 | 10 | 10 | 10 |
| 10 minutes | 10 | 20 | 30 | 30 |
| 10 minutes | 20 | 40 | 60 | 120 |
| 10 minutes | 40 | 80 | 120 | 240 |
| Remaining infusion | 80 | 160 | 240 | 300 |
If you get a leak at the infusion site
Ask your doctor, pharmacist, or nurse if another needle size would be better for you.
All changes regarding needle size must be monitored by your treating physician.
If you use more HyQvia than you should
If you think you have used too much HyQvia, talk to your doctor as soon as possible.
If you forget to use HyQvia
Do not infuse double dose HyQvia to compensate for the missed dose. If you think you have missed a dose, talk to your doctor as soon as possible.
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.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Some side effects such as headaches, chills, and body aches can be reduced by reducing the infusion rate.
Serious side effects are
Infusion of drugs such as HyQvia can sometimes lead to serious, but rare, allergic reactions. You may experience a sudden drop in blood pressure and in some cases anaphylactic shock.
Your doctor will be aware of these possible side effects and will monitor you during and after the initial infusions.
Typical signs or symptoms include 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.
- If you notice any of these signs during infusion , talk to a doctor or nurse immediately.
- When using HyQvia at home, you must perform an infusion in the presence of a designated supervisor. The supervisor will help you detect allergic reactions, stop the infusion and get help if needed.
- See also section 2 of this leaflet for the risk of allergic reactions and the use of HyQvia in the home.
Very common side effects (may affect more than 1 in 10 people ):
Pain at the infusion site, including mild to moderate discomfort and tenderness. The reactions usually disappear within a few days
Common side effects (may affect up to 1 in 10 people ):
Infusion site reactions: These include redness, swelling, itching, calluses, and rash at the infusion site. The reactions usually disappear within a few days. Headache, fatigue, nausea, vomiting, diarrhea, abdominal pain, muscle or joint pain, chest pain, fever, weakness, or malaise.
Uncommon side effects (may affect up to 1 in 100 people ):
Chills, migraines , high blood pressure, distended abdomen, skin rash / allergic rash / redness, itching , pain in the chest, arms and / or legs, swollen genitals (a result of the swelling spreading from the infusion site), swollen legs, feet and ankles, positive blood test for the antibody ‘s
No known frequency (cannot be calculated from the available data):
Hypersensitivity, influenza-like illness and infusion site leakage, meningitis (aseptic meningitis ).
Side effects have been observed with similar drugs
The following side effects have been observed with the infusion of drugs such as human normal immunoglobulin 10% given subcutaneously ( subcutaneously ). Although these side effects have not been observed with HyQvia so far, it is possible that someone using HyQvia may get them:
Tingling, tremors, tingling sensation in the mouth, rapid heartbeat, allergic reactions, hemorrhage or pallor, cold hands or feet, shortness of breath,
swelling of the face, abnormal sweating, muscle stiffness, blood tests showing changes in liver function (elevated ALT ).
The following rare side effects have been observed in patients using drugs such as human normal immunoglobulin 10% given intravenously ( intravenously ). These side effects have not been observed with HyQvia, but there is a small possibility that someone using HyQvia may get them:
Blood clots in the blood vessels (thromboembolic reactions) leading to heart attack, stroke , blockage of the deep veins or of the blood vessels that supply the lung (pulmonary embolism), kidney disease or kidney failure , destruction of red blood cells ( hemolysis ).
Reporting of side effects
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. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store HyQvia
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.
Store in a refrigerator (2 ° C-8 ° C). Do not freeze.
Do not shake.
Store the vials in the outer carton. Sensitive to light.
Do not use this medicine if the solutions are cloudy or contain particles or precipitates.
The unused solution in opened vials should be discarded.
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
HyQvia is a device with two vials containing:
- a solution of recombinant human hyaluronidase (step 1 in HyQvia / infuse it first) and
- a solution with human normal immunoglobulin 10% (step 2 in HyQvia / infuse this last).
The contents of each vial are described below:
- Recombinant human hyaluronidase
This vial contains recombinant human hyaluronidase.
The other ingredients are sodium chloride, sodium phosphate, human albumin, ethylenediaminetetraacetic acid ( EDTA ), disodium, calcium chloride and water for injections (see also section 2, “HyQvia contains sodium” ). - Human normal immunoglobulin 10%
One ml of the solution in this vial contains 100 mg of human normal immunoglobulin of which at least 98% is immunoglobulin G (IgG).
The active substance in HyQvia is human normal immunoglobulin. The medicinal product contains trace amounts of immunoglobulin A ( IgA ) (not more than 140 micrograms / ml, 37 micrograms on average).
The other ingredients in this vial are glycine and water for injections.
What the medicine looks like and contents of the pack
HyQvia is delivered as a package containing:
- a glass vial of recombinant human hyaluronidase, and
- a glass vial of human normal immunoglobulin 10%.
Recombinant human hyaluronidase is a clear and colorless solution.
Human normal immunoglobulin 10% is a clear and colorless or slightly yellow solution.
The following pack sizes are available:
| Recombinant human hyaluronidase | Human normal immunoglobulin 10% | |
| Volume (ml) | Protein (grams) | Volume (ml) |
| 1.25 | 2.5 | 25 |
| 2.5 | 5 | 50 |
| 5 | 10 | 100 |
| 10 | 20 | 200 |
| 15 | 30 | 300 |
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Baxalta Innovations GmbH
Industriestrasse 67
A 1221 Vienna
Austria
Tel .: +800 66838470
Email: medinfoEMEA@shire.com
Manufacturer
Baxalta Belgium Manufacturing SA
Boulevard René Branquart 80
B ‑ 7860 Lessines
Belgium