600 mg injection, solution in the vial
trastuzumab

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.
  • 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 you will find information about:
1. What Herceptin is and what it is used for
2. What you need to know before you get Herceptin
3. How to get Herceptin
4. Possible side effects
5. How to store Herceptin
6. Contents of the packaging and other information

1. What Herceptin is and what it is used for

Herceptin contains the active substance trastuzumab, which is a monoclonal antibody. Monoclonal antibodies are attached to specific proteins or antigens. Trastuzumab is designed to bind selectively to an antigen called human epidermal growth factor receptor 2 ( HER2 ). HER2 is found in large amounts on the surface of certain cancer cells ( HER2 -positive cancer) and then stimulates cell growth. When Herceptin binds to HER2, the growth of the cancer cells is stopped, which leads to their death.

Your doctor may prescribe Herceptin for the treatment of breast cancer then:

  • You have early breast cancer with high levels of protein et HER2 .
  • You have metastatic breast cancer (breast cancer that has spread outside the original tumor ) with high levels of HER2 . Herceptin is prescribed in combination with chemotherapy are paclitaxel or docetaxel as first treatment for metastatic breast cancer, or it can be prescribed as a sole treatment in conditions where other treatments proved unsuccessful. It is also used in combination with medicines called aromatase inhibitors for the treatment of patients with high levels of HER2 and hormone receptor positive metastatic (spread) breast cancer (cancer that is sensitive to the presence of female sex hormone).

2. What you need to know before you get Herceptin

Do not use Herceptin if:

  • you are allergic to trastuzumab (the active substance in this medicine), murine (mouse) protein , or any of the other ingredients of this medicine (listed in section 6).
  • you have severe breathing problems at rest due to your cancer or if you need oxygen therapy.

Warnings and cautions

Your doctor will closely monitor your treatment with Herceptin.

Control of the heart

Treatment with Herceptin alone or with a taxane can affect the heart, especially if you have previously been treated with an anthracycline (taxanes and anthracyclines are two other types of medicines used to treat cancer). The effects can be moderate to severe and some patients have died. Your heart function will therefore be checked before and during treatment (every three months) and after (up to two to five years) treatment with Herceptin. If you develop signs of heart failure (ie insufficient pumping of blood from the heart), your heart function may be checked more often (every six to eight weeks). You may then receive treatment for heart failure or you may need to discontinue treatment with Herceptin.

Talk to your doctor, pharmacist, or nurse before receiving Herceptin about:

  • you have had heart failure , coronary heart disease, heart valve disease ( wheezing on the heart) or high blood pressure or if you have taken or are currently taking medicines for high blood pressure .
  • you have previously received or are currently receiving a medicine called doxorubicin or epirubicin (a medicine used to treat cancer). These medicines (or other anthracyclines ) can damage the heart muscle and increase the risk of heart problems with Herceptin.
  • you suffer from shortness of breath, especially if you are treated with a taxane at the same time. Herceptin can cause breathing difficulties, especially when given for the first time. This can be more serious if you are already short of breath. Patients with severe respiratory distress have in very rare cases died in connection with Herceptin treatment.
  • you have previously received any other treatment for cancer.

If you are taking Herceptin with paclitaxel, docetaxel, an aromatase inhibitor, carboplatin, or cisplatin, you should also read the package leaflets for these products carefully.

Children and young people

Herceptin is not recommended for anyone under 18 years of age.

Other medicines and Herceptin

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

It can take up to 7 months for Herceptin to be removed from the body. You should therefore tell your doctor, pharmacist, or nurse that you have been treated with Herceptin if you start any new medication within 7 months of stopping treatment.

Pregnancy

  • If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before taking this medicine.
  • You should use effective contraception during treatment with Herceptin and for at least 7 months after stopping treatment.

Your doctor will advise you on the disadvantages and benefits of taking Herceptin during pregnancy. In rare cases, pregnant women treated with Herceptin have seen a decrease in the amount of (fetal) fluid that surrounds the growing fetus in the womb. This condition can be harmful to your baby in the womb and has been associated with the lungs not developing fully, resulting in fetal death.

Breast-feeding

Do not breastfeed your baby during treatment with Herceptin and within 7 months after the last dose of Herceptin as Herceptin may pass to your baby through breast milk.

Consult a doctor, pharmacist, or nurse before taking any medicine.

Driving and using machines

Herceptin may affect your ability to drive or use machines. If you experience symptoms such as dizziness, drowsiness, chills, or fever during treatment, you should not drive or use machines until these symptoms have disappeared.

Sodium

Herceptin contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘sodium-free.

3. How to get Herceptin

Before starting treatment, your doctor will decide if your tumor is HER2- positive. Only patients with HER2 -positive cancer (large amounts of HER2 ) will be treated with Herceptin. Herceptin should only be given by a doctor or nurse.

There are two different forms (dosage forms) of Herceptin:

  • one is given as an infusion into a vein ( intravenous infusion )
  • the other is given as an injection under the skin ( subcutaneous injection ).

It is important to check the labeling of the product to ensure that the correct dosage form is given to the patient, and complies with the prescribed medication. Herceptin subcutaneous formulation is not intended for intravenous administration and should only be administered by subcutaneous injection.

Your doctor may consider switching your Herceptin intravenous therapy to Herceptin subcutaneous therapy (and vice versa) if it is deemed appropriate for you.

To prevent medication errors, it is important to check the label of the vial to ensure that the medicine is prepared and administered is Herceptin (trastuzumab) and not any other product containing trastuzumab (eg trastuzumab emtansine or trastuzumab deruxtecan).

The recommended dose is 600 mg. Herceptin is given as a subcutaneous injection (under the skin) for 2 to 5 minutes every three weeks.

The injection site should be alternated between the left and right thighs. Injection should be given at least 2.5 cm away from the previous injection site, and never in areas where the skin is red, bruised, tender, or hard.

If other subcutaneous drugs are used during treatment with Herceptin subcutaneous formulation, the drugs should be given at different injection sites on the body.

Herceptin must not be mixed or diluted with other medicines.

If you stop using Herceptin

Do not stop using this medicine without talking to your doctor first. All doses should be taken at the right time every three weeks. This helps the drug to work as well as possible.

It can take up to 7 months before Herceptin disappears from the body. Therefore, your doctor may decide to continue to monitor your heart function even after treatment is stopped.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of these side effects may be serious and may involve hospitalization.

During treatment with Herceptin, chills, fever and other flu-like symptoms may occur. These side effects are very common (may affect more than 1 in 10 people). Other symptoms include: nausea, vomiting, pain, increased muscle tension and tremor, headache, dizziness, difficulty breathing, high or low blood pressure, altered heart rhythm (palpitations, palpitations, or irregular heartbeat), swelling of the face and lips, rash, and lethargy. Some of these symptoms may be severe and some patients have died (see section “Warnings and precautions”).

Your doctor or nurse will check for any side effects during injection one and for 30 minutes after the first injection one and for 15 minutes after the second injection.

Serious side effects are

Other side effects may occur at any time during treatment with Herceptin. Tell a doctor or nurse immediately if you notice any of the following side effects:

  • Heart problems can sometimes occur during treatment and sometimes after treatment has stopped and can be serious. They include weakening of the heart muscle which can possibly lead to heart failure , inflammation around the heart and altered heart rhythm. This can lead to symptoms such as shortness of breath (including shortness of breath during the night), cough, fluid retention (swelling) in the legs or arms, palpitations (heart flutter or irregular heartbeat) (see section 2. Checking the heart).

Your doctor will check your heart regularly during and after treatment, but you should tell your doctor immediately if you experience any of the above symptoms.

  • Tumor light syndrome (group of metabolic complications that occur after cancer treatment and are characterized by high levels of potassium and phosphate in the blood and low levels of calcium in the blood). Symptoms may include kidney problems (weakness, shortness of breath, fatigue and confusion), heart problems (heart flutter with a faster or slower heartbeat), cramps, vomiting or diarrhea and tingling in the mouth, hands or feet.

If you experience any of the above symptoms after stopping your treatment with Herceptin, talk to your doctor and tell your doctor that you have previously been treated with Herceptin.

There are two different forms (dosage forms) of Herceptin:

  • one given as an infusion into a vein for 30 to 90 minutes
  • the other is given as a subcutaneous injection (under the skin) for 2 to 5 minutes.

In the clinical study comparing these two dosage forms, infection and cardiac side effects leading to hospitalization were more common with the subcutaneous dosage form. There were also more local reactions at the injection site and more people had high blood pressure. Other side effects were comparable.

Very common side effects of Herceptin may occur in more than 1 in 10 patients

  • infection is
  • diarrhea
  • constipation
  • heartburn ( dyspepsia )
  • fatigue
  • rash
  • chest pain
  • abdominal pain
  • joint pain
  • low levels of red blood cells and white blood cells (which help the body fight you infection ) sometimes with fever
  • muscle pain.
  • conjunctivitis (conjunctivitis of the eye)
  • watery eyes
  • nosebleeds
  • rinnsnuva
  • hair loss
  • tremors
  • hot flashes
  • dizziness
  • nail changes
  • weight loss
  • loss of appetite
  • insomnia ( insomnia )
  • taste changes
  • decreased platelet count
  • bruises
  • numbness or tingling in the fingers and toes, which can sometimes spread to the rest of the arm or leg
  • redness , swelling or sores in the mouth and / or throat
  • pain, swelling, redness or tingling in the hands and / or feet
  • shortness of breath
  • headache
  • cough
  • vomiting
  • nausea

Common side effects of Herceptin may occur in up to 1 in 10 patients

allergic reactions dry eyes
throat infection sweating
infection you in the bladder and on the skin feeling of weakness and not feeling well
concern
inflammation of the chest Depression
inflammation of the liver
kidney effects asthma
increased muscle tone or tension (hypertension) lung infection
pain in arms and / or legs lung impact
itchy rash back pain
drowsiness ( somnolence ) neck pain
hemorrhoids  skeletal pain
itching acne
dry mouth and skin leg cramps

Uncommon side effects for Herceptin : may affect up to 1 in 100 people

  • deafness
  • lumpy skin rash
  • hissing / wheezing breathing
  • inflammation or scarring of the lungs

Rare side effects for Herceptin : may affect up to 1 in 1,000 people

  • jaundice
  • anaphylactic reactions

Other side effects reported with Herceptin no known frequency (can not be calculated from the available data)

  • abnormal or impaired blood coagulation (blood clotting)
  • high potassium levels
  • swelling or bleeding behind the eyes
  • shock
  • abnormal heart rhythm
  • respiratory distress
  • breathing problems
  • acute accumulation of fluid in the lungs
  • acutely narrower airways
  • abnormally low oxygen content in the blood
  • difficulty breathing when lying upright
  • liver damage
  • swelling of the face, lips and neck
  • kidney failure
  • abnormally little amniotic fluid around the fetus in the womb
  • underdeveloped lungs of the fetus in utero
  • abnormal development of the kidneys of the fetus in the womb

Some of the side effects you are experiencing may be due to your underlying breast cancer disease. If you are treated with Herceptin with chemotherapy you can some of the side effects are also due to chemotherapy engines.

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 Herceptin

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 outer carton (EXP) and on the vial label (EXP). The expiration date is the last day of the specified month.

Store in a refrigerator (2 ºC – 8 ºC).

Keep the vial in the outer carton. Sensitive to light.

Do not freeze.

After opening the vial, the solution should be used immediately.

Do not use this medicine if you see particles or discoloration before administration .

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

  • The active substance is trastuzumab. A vial of 5 ml containing 600 mg trastuzumab.
  • The other ingredients are recombinant human hyaluronidase (rHuPH20), L ‑ histidine, L ‑ histidine hydrochloride monohydrate, α, α ‑ trehalose dihydrate, L-methionine, polysorbate 20, water for injections.

What the medicine looks like and contents of the pack

Herceptin is a solution for injection in a glass vial with a rubber stopper and contains 5 ml (600 mg) of trastuzumab. Clear to opalescent, colorless to pale yellow.

Each carton contains 1 vial .

Marketing Authorisation Holder

Roche Registration GmbH

Emil-Barell-Strasse 1

79639 Grenzach-Wyhlen

Germany

Manufacturer

Roche Pharma AG
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

Contact the representative of the marketing authorization holder to find out more about this medicine:

Sverige
Roche AB
Tel: +46 (0) 8 726 1200
Suomi / Finland
Roche Oy
Puh / Tel: +358 (0) 10 554 500

Muhammad Nadeem

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