PANZYGA 100 mg/mL SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Panzyga 100mg/ml solution for infusion

Human normal immunoglobulin (IgIV)

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Panzyga and what is it used for

What is Panzyga

This medicine is a solution of human normal immunoglobulin (IgG), i.e. a solution of human antibodies, for intravenous administration (i.e. infusion into a vein). Immunoglobulins are normal components of human blood and support the body's immune defenses. Panzyga contains all the IgG found in the blood of healthy individuals. Adequate doses of Panzyga can restore abnormally low IgG levels to normal values.

Panzyga has a broad spectrum of antibodies against different infectious agents.

What is Panzyga used for

Panzyga is used as replacement therapy in children, adolescents (0-18 years) and adults in different patient groups:

• Patients with congenital antibody deficiency (primary immunodeficiency syndromes, such as: congenital agammaglobulinemia and hypogammaglobulinemia, common variable immunodeficiency, severe combined immunodeficiencies)
• Patients with antibody deficiency (secondary immunodeficiency) due to specific diseases and/or treatments and who experience severe or recurrent infections.

This medicine may be used for the treatment of adults and children and adolescents (0-18 years) who are vulnerable and have been exposed to measles or are at risk of exposure to measles and in whom active vaccination against measles is not indicated or not recommended.

Panzyga may also be used in the treatment of the following autoimmune disorders (immunomodulation):

• In patients with immune thrombocytopenia (ITP), a disease in which platelets are destroyed and their number is reduced, and who are at high risk of bleeding or before surgery to correct platelet count.
• In patients with Kawasaki disease, a disease that leads to inflammation of several organs
• In patients with Guillain-Barré syndrome, a disease that leads to inflammation of certain parts of the nervous system
• In patients with chronic inflammatory demyelinating polyneuropathy (CIDP), a disease that leads to chronic inflammation of the peripheral nervous system and causes muscle weakness and/or numbness mainly in the legs and arms.

In patients with multifocal motor neuropathy (MMN), a condition characterized by slowly progressive asymmetric weakness of the limbs without sensory loss.

2. What you need to know before you use Panzyga

Do not use Panzyga:

• if you are allergic to human normal immunoglobulin or to any of the other ingredients of this medicine (listed in section 6).
• if you have a deficiency in immunoglobulin A (IgA deficiency) and if you have developed antibodies against IgA immunoglobulins.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Panzyga.

It is strongly recommended that each time you receive a dose of Panzyga, the name and batch number of the product should be recorded in order to maintain a record of the batches used.

Certain adverse reactions may occur more frequently:

• in case of high infusion rate
• when you receive Panzyga for the first time or, in rare cases, when there has been a long interval since the previous infusion.
• when you have an untreated infection or underlying chronic inflammation

In case of an adverse reaction, your doctor will reduce the infusion rate or stop the infusion. The necessary treatment of the adverse event will depend on the nature and severity of the event.

Circumstances and conditions that increase the risk of having side effects

• After administration of Panzyga, thromboembolic events such as heart attack, stroke, and deep vein obstruction, for example, in the lower leg, or pulmonary vessel obstruction may occur very rarely. These types of events occur more frequently in patients with risk factors, such as obesity, advanced age, hypertension, diabetes, previous episodes of these events, prolonged periods of immobilization, and intake of certain hormones (e.g. "the pill"). Make sure to drink fluids adequately. Additionally, Panzyga should be administered as slowly as possible.

If you have had kidney problems in the past or if you have certain risk factors such as diabetes, overweight, or are over 65 years of age, Panzyga should be administered as slowly as possible because cases of acute kidney failure have been reported in patients with these risk factors. Inform your doctor, even if any of the above circumstances have occurred in the past.

• Patients with blood groups A, B, or AB, as well as patients with certain inflammatory diseases, have a higher risk of the administered immunoglobulins destroying red blood cells (which is called hemolysis).

When may it be necessary to reduce the infusion rate or stop the infusion?

• Severe headaches and stiffness in the neck may occur rarely, from several hours to 2 days after treatment with Panzyga.
• Allergic reactions are rare, but can induce anaphylactic shock, even in patients who have tolerated previous treatments.

A sudden drop in blood pressure or shock may be consequences of an anaphylactic reaction.

• In very rare cases, acute lung injury related to transfusion (TRALI) may occur after receiving immunoglobulins, including Panzyga. This will lead to non-cardiac accumulation of fluid in the lung air spaces. You will recognize TRALI by significant difficulty breathing, with normal heart function and increased body temperature (fever). Symptoms usually appear between 1 and 6 hours after receiving treatment.

Consult your doctor or healthcare professional immediately if you notice any of the above symptoms during or after Panzyga infusion, who will decide whether to reduce the infusion rate or stop it completely, as well as whether further measures are needed.

• On occasion, immunoglobulin solutions like Panzyga may trigger a decrease in the number of white blood cells. This disorder usually resolves spontaneously within 1 to 2 weeks.

Effects on blood tests

Panzyga contains a wide variety of different antibodies, some of which may affect blood tests. If you have a blood test after receiving Panzyga, inform the person taking the blood or your doctor that you have received a human normal immunoglobulin solution.

Viral safety

When medicines are manufactured from human blood or plasma, certain measures are put in place to prevent the transmission of infections to patients. These include:

• Careful selection of blood or plasma donors to ensure that those at risk of carrying infections are excluded.
• Testing for specific infection markers in individual donations and in plasma pools for signs of virus/infection.
• Steps included by manufacturers in the processing of blood or plasma to inactivate or remove viruses.

Despite these measures, when medicines derived from human blood or plasma are administered, the possibility of transmitting an infection cannot be completely excluded. This also applies to any unknown or emerging virus or other types of infections.

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

Immunoglobulins have not been associated with hepatitis A or parvovirus B19 infections, possibly due to antibodies against these infections found in the product, which have a protective effect.

Children and adolescents

There are no specific or additional warnings or precautions applicable to children and adolescents.

Using Panzyga with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription, or if you have been given a vaccine in the last three months.

During treatment with Panzyga, concomitant use of medicines that increase water excretion from the body (loop diuretics) should be avoided. Your doctor will decide whether you should use or continue treatment with loop diuretics.

Panzyga may alter the effect of live attenuated virus vaccines such as

• measles,
• rubella,
• mumps,
• chickenpox.

A period of 3 months should elapse after administration of this product before vaccination with live attenuated virus vaccines. In the case of measles, this alteration may persist for up to 1 year.

Using Panzyga with food, drinks, and alcohol

No effects have been observed. Adequate hydration should be ensured before infusion of the medicine.

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 or continuing to use this medicine.

The safety of this product during pregnancy has not been determined in controlled clinical trials and, therefore, should be administered with caution to pregnant and breastfeeding women. It has been shown that immunoglobulin products cross the placenta, especially during the third trimester. Clinical experience with immunoglobulins indicates that no harmful effects are expected during pregnancy, in the fetus, or in the newborn.

Immunoglobulins are excreted in breast milk, so no negative effects are expected in neonates who are being breastfed or in infants.

Driving and using machines

This medicine has no or negligible influence on the ability to drive or use machines. However, patients who experience side effects during treatment should wait until they resolve before driving or using machines.

Panzyga contains sodium

This medicine contains 69 mg of sodium (main component of cooking/table salt) in each 100 ml vial. This is equivalent to 3.45% of the maximum recommended daily sodium intake for an adult.

This should be taken into account in patients on a low-sodium diet.

3. How to use Panzyga

Your doctor will decide if you need Panzyga and in what dose. The administration of the medicine by intravenous infusion (infusion into a vein) is the responsibility of healthcare personnel. The dose and dosing regimen depend on the indication and may need to be adjusted individually for each patient.

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

Use in children and adolescents

The administration (by intravenous route) of the medicine in children and adolescents (0-18 years) does not differ from administration in adults.

If you receive more Panzyga than you should

It is very unlikely that an overdose will occur because this medicine is usually administered under medical supervision. If, despite this, you receive more Panzyga than you should, the blood may become too thick (hyperviscous), which can increase the risk of blood clots. This can occur especially if you are a high-risk patient, such as if you are elderly or have heart or kidney disease. Make sure to stay well-hydrated. Inform your doctor if you have any known medical problems.

If you forget to use Panzyga

Consult your doctor to discuss how to proceed.

4. Possible side effects

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

Consult your doctor as soon as possible if you experience any of the following serious side effects (all are very rare and may affect up to 1 in 10,000 infusions). In some cases, your doctor may need to interrupt treatment and reduce your dose, or stop treatment:

• Facial, tongue, and tracheal inflammationthat can cause great difficulty breathing
• Sudden allergic reactionwith difficulty breathing, rash, wheezing, and low blood pressure
• Strokethat can cause weakness and/or loss of sensation on one side of the body
• Heart attackthat causes chest pain
• Blood clotthat causes pain and inflammation of the limbs
• Pulmonary embolismthat causes chest pain and difficulty breathing
• Anemiathat causes difficulty breathing or pallor
• Severe kidney disorderthat can cause you not to urinate
• A pulmonary conditioncalled transfusion-related acute lung injury (TRALI) that causes difficulty breathing, blue discoloration of the skin, fever, and low blood pressure

If you experience any of the above symptoms, contact your doctor as soon as possible.

The following side effects have also been reported:

Common side effects(may affect up to 1 in 10 infusions):

Headache, nausea, fever

Uncommon side effects(may affect up to 1 in 100 infusions):

Rash, back pain, chest pain, chills, dizziness, fatigue, cough, vomiting, abdominal pain, diarrhea, joint pain, muscle pain, itching at the infusion site, rash, neck pain, arm or leg pain, reduced sense of touch or sensation, reduced red blood cells, reduced white blood cells, aseptic meningitis (see also section Warnings and precautions), itching in the eyes, rapid heart rate, high blood pressure, ear pain, stiffness, feeling of cold, feeling of heat, discomfort, chills, numbness, changes in blood tests that inform about liver function.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system. By reporting side effects, you can help provide more information on the safety of this medicine.

Spain

Spanish Medicines Vigilance System for Human Use:

www.notificaRAM.es

5. Storage of Panzyga

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. The expiry date is the last day of the month stated.

Store in a refrigerator (between 2°C and 8°C). Keep the container in the outer packaging to protect it from light. Do not freeze.

The medicine can be removed from the refrigerator for a period of 12 months (without exceeding the expiry date) and stored below 25°C. During this period, the medicine should not be refrigerated again. Discard the medicine if it is not used during this period or after the expiry date, whichever comes first. Record the date on which the product was removed from the refrigerator on the outer packaging.

Do not use this medicine if you notice that the solution is turbid, has deposits, or has an intense color.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Contents and Additional Information

Panzyga Composition

• The active ingredient is normal human immunoglobulin (human antibodies). Panzyga contains 100 mg/ml of human proteins, of which at least 95% is immunoglobulin G (IgG).
• The other components are glycine and water for injectable preparations.

Panzyga Appearance and Container Contents

Infusion solution available in vials (1 g/10 ml, 2.5 g/25 ml) or bottles (5 g/50 ml, 6 g/60 ml, 10 g/100 ml, 20 g/200 ml, 30 g/300 ml).

Container sizes:

1 vial (1 g/10 ml or 2.5 g/25 ml)

1 bottle (5 g/50 ml; 6 g/60 ml; 10 g/100 ml; 20 g/200 ml; 30 g/300 ml)

3 bottles (3 x 10 g/100 ml or 3 x 20 g/200 ml)

The solution is transparent or slightly opalescent, colorless or slightly yellow.

Only some container sizes may be marketed.

Marketing Authorization Holder

Octapharma S.A.

Avda. Castilla, 2. (P.E. San Fernando) Ed. Dublín, 2ª Planta 28830 San Fernando de Henares, Madrid

Manufacturers

Octapharma

72 rue du Maréchal Foch, 67380 Lingolsheim, France

Octapharma Pharmazeutika Produktionsges.m.b.H.

Oberlaaer Strasse 235, 1100 Vienna, Austria

Octapharma GmbH

Elisabeth-Selbert-Str. 11, 40764 Langenfeld, Germany

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of the last revision of this leaflet:July 2024

This information is intended only for healthcare professionals:

• The medicinal product should be brought to room temperature or body temperature before use.
• The solution should be from transparent to slightly opalescent and from colorless to slightly yellow.
• Turbid solutions or those with sediment should not be used.
• Unused medicinal product or waste material should be disposed of in accordance with local requirements.
• This medicinal product should not be mixed with other medicinal products.
• In order to finish the infusion of the medicinal product that may have remained in the tubes at the end of the infusion, a 0.9% saline solution (9 mg/ml) or 5% dextrose solution (50 mg/ml) can be circulated through the tube.