Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - ogivri

Document Subject

Generated Narrative: MedicinalProductDefinition mp3063ae54c8b95c21a8b236c970f9eb21

identifier: http://ema.europa.eu/identifier/EU/1/18/1341/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Ogivri 150 mg powder for concentrate for solution for infusion

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-3063ae54c8b95c21a8b236c970f9eb21

identifier: http://ema.europa.eu/identifier/EU/1/18/1341/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - ogivri

Attesters

What is in this leaflet

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

Ogivri contains the active substance trastuzumab, which is a monoclonal antibody. Monoclonal antibodies attach 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 some cancer cells where it stimulates their growth. When Ogivri binds to HER2 it stops the growth of such cells and causes them to die.

Your doctor may prescribe Ogivri for the treatment of breast and gastric cancer when:

• You have early breast cancer, with high levels of a protein called HER2. * You have metastatic breast cancer (breast cancer that has spread beyond the original tumour) with high levels of HER2. Ogivri may be prescribed in combination with the chemotherapy medicine paclitaxel or docetaxel as first treatment for metastatic breast cancer or it may be prescribed alone if other treatments have proved unsuccessful. It is also used in combination with medicines called aromatase inhibitors with patients with high levels of HER2 and hormone receptor-positive metastatic breast cancer (cancer that is sensitive to the presence of female sex hormones).
• You have metastatic gastric cancer with high levels of HER2, when it is in combination with the other cancer medicines capecitabine or 5-fluorouracil and cisplatin.

Do not use Ogivri:

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

Warnings and precautions
Your doctor will closely supervise your therapy. Heart checks Treatment with Ogivri alone or with a taxane may affect the heart, especially if you have ever used an anthracycline (taxanes and anthracyclines are two other kinds of medicine used to treat cancer). The effects may be moderate to severe and could cause death. Therefore, your heart function will be checked before, during (every three months) and after (up to two to five years) treatment with Ogivri. If you develop any signs of heart failure (inadequate pumping of blood by the heart), your heart function may be checked more frequently (every six to eight weeks), you may receive treatment for heart failure or you may have to stop Ogivri treatment.

Talk to your doctor, pharmacist or nurse before you are given Ogivri if:

• you have had heart failure, coronary artery disease, heart valve disease (heart murmurs), high blood pressure, taken any high blood pressure medicine or are currently taking any high blood pressure medicine.

• you have ever had or are currently using a medicine called doxorubicin or epirubicin (medicines used to treat cancer). These medicines (or any other anthracyclines) can damage heart muscle and increase the risk of heart problems with Ogivri.

• you suffer from breathlessness, especially if you are currently using a taxane. Ogivri can cause breathing difficulties, especially when it is first given. This could be more serious if you are already breathless. Very rarely, patients with severe breathing difficulties before treatment have died when they were given Ogivri.

• you have ever had any other treatment for cancer.

If you receive Ogivri with any other medicine to treat cancer, such as paclitaxel, docetaxel, an aromatase inhibitor, capecitabine, 5-fluorouracil, or cisplatin you should also read the patient information leaflets for these products.

Children and adolescents Ogivri is not recommended for anyone under the age of 18 years.

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

It may take up to 7 months for Ogivri to be removed from the body. Therefore, you should tell your doctor, pharmacist or nurse that you have had Ogivri if you start any new medicine in the 7 months after stopping treatment.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before taking this medicine.

Pregnancy

• You should use effective contraception during treatment with Ogivri and for at least 7 months after treatment has ended.
• Your doctor will advise you of the risks and benefits of taking Ogivri during pregnancy. In rare cases, a reduction in the amount of (amniotic) fluid that surrounds the developing baby within the womb has been observed in pregnant women receiving trastuzumab. This condition may be harmful to your baby in the womb and has been associated with the lungs not developing fully resulting in foetal death.

Breast-feeding

Do not breast-feed your baby during Ogivri therapy and for 7 months after the last dose of Ogivri as this medicine may pass to your baby through your breast milk. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines Ogivri may affect your ability to drive a car or operate machines. If during treatment you experience symptoms, such as dizziness, sleepiness, chills or fever, you should not drive or use machines until these symptoms disappear.

Ogivri contains sorbitol (E420) and sodium Ogivri 150 mg powder for concentrate for solution for infusion. This medicine contains 115.2 mg sorbitol in each vial.

Ogivri 420 mg powder for concentrate for solution for infusion. This medicine contains 322.6 mg sorbitol in each vial.

Sorbitol is a source of fructose. If you have hereditary fructose intolerance (HFI), a rare genetic disorder, you must not receive this medicine. Patients with HFI cannot break down fructose, which may cause serious side effects.
You must tell your doctor before receiving this medicine if you have HFI or if you can no longer take sweet foods or drinks because you feel sick, vomit or get unpleasant effects such as bloating, stomach cramps or diarrhoea.

Ogivri contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially sodium free .

Before starting the treatment your doctor will determine the amount of HER2 in your tumour. Only patients with a large amount of HER2 will be treated with Ogivri. Ogivri should only be given by a doctor or nurse. Your doctor will prescribe a dose and treatment regimen that is right for you. The dose of Ogivri depends on your body weight.

The first dose of your treatment is given over 90 minutes and you will be observed by a health professional while it is being given in case you have any side effects. If the first dose is well tolerated the next doses may be given over 30 minutes (see section 2 under Warnings and precautions ). The number of infusions you receive will depend on how you respond to the treatment. Your doctor will discuss this with you.

Ogivri is given as an infusion into a vein (intravenous infusion, drip), this intravenous formulation is not for subcutaneous use and should be given as an intravenous infusion only.

For early breast cancer, metastatic breast cancer and metastatic gastric cancer, Ogivri is given every 3 weeks. Ogivri may also be given once a week for metastatic breast cancer.

In order to prevent medication errors it is important to check the vial labels to ensure that the medicine being prepared and given is Ogivri (trastuzumab) and not another trastuzumab-containing product (e.g. trastuzumab emtansine or trastuzumab deruxtecan).

If you stop using Ogivri Do not stop using this medicine without talking to your doctor first. All doses should be taken at the right time every week or every three weeks (depending on your dosing schedule). This helps your medicine work as well as it can.

It may take up to 7 months for Ogivri to be removed from your body. Therefore, your doctor may decide to continue to check your heart functions, even after you finish treatment.

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

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

Some of these side effects may be serious and may lead to hospitalisation.

During an Ogivri infusion, chills, fever and other flu like symptoms may occur. These are very common (may affect more than 1 in 10 people).
Other infusion-related symptoms are: feeling sick (nausea), vomiting, pain, increased muscle tension and shaking, headache, dizziness, breathing difficulties, high or low blood pressure, heart rhythm disturbances (palpitations, heart fluttering or irregular heart beat), swelling of the face and lips, rash and feeling tired.
Some of these symptoms can be serious and some patients have died (see section 2 under Warnings and precautions ).

These effects mainly occur with the first intravenous infusion ( drip into your vein) and during the first few hours after the start of the infusion. They are usually temporary. You will be observed by a health care professional during the infusion and for at least six hours after the start of the first infusion and for two hours after the start of other infusions. If you develop a reaction, they will slow down or stop the infusion and may give you treatment to counteract the side effects. The infusion may be continued after the symptoms improve.

Occasionally, symptoms start later than six hours after the infusion begins. If this happens to you, contact your doctor immediately. Sometimes, symptoms may improve and then get worse later.

Serious side effects Other side effects can occur at any time during treatment with Ogivri, not just related to an infusion. Tell a doctor or nurse straight away, if you notice any of the following side effects:

• Heart problems can sometimes occur during treatment and occasionally after treatment has stopped and can be serious. They include weakening of the heart muscle possibly leading to heart failure, inflammation of the lining around the heart and heart rhythm disturbances. This can lead to symptoms such as breathlessness (including breathlessness at night), cough, fluid retention (swelling) in the legs or arms, palpitations (heart fluttering or irregular heart beat) (see Heart checks in section 2).

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

• Tumour lysis syndrome (a group of metabolic complications occurring after cancer treatment characterised by high blood levels of potassium and phosphate, and low blood levels of calcium). Symptoms may include kidney problems (weakness, shortness of breath, fatigue and confusion), heart problems (fluttering of the heart or a faster or slower heartbeat), seizures, vomiting or diarrhoea and tingling in the mouth, hands or feet.

If you experience any of the above symptoms when your treatment with Ogivri has finished, you should see your doctor and tell them that you have previously been treated with Ogivri.

Very common side effects (may affect more than 1 in 10 people):

• infections
• diarrhoea
• constipation
• heartburn (dyspepsia)
• fatigue
• skin rashes
• chest pain
• abdominal (stomach) pain
• joint pain
• low counts of red blood cells and white blood cells (which help fight infection) sometimes with fever
• muscle pain
• conjunctivitis (discharge with itching of the eyes and crusty eyelids)
• watery eyes
• nose bleeds
• runny nose
• hair loss
• tremor
• hot flush
• dizziness
• nail disorders
• weight loss
• loss of appetite
• inability to sleep (insomnia)
• altered taste
• low platelet count
• bruising
• numbness or tingling of the fingers and toes, which occasionally may extend to the rest of the limb
• redness, swelling or sores in your mouth and/or throat
• pain, swelling, redness or tingling of hands and/or feet
• breathlessness
• headache
• cough
• vomiting
• nausea (feeling sick)

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

• allergic reactions

• dry mouth and skin

• throat infections

• dry eyes

• bladder and skin infections

• sweating

• feeling weak and unwell

• inflammation of the breast

• anxiety

• inflammation of the liver

• depression

• kidney disorders

• increased muscle tone or tension (hypertonia)

• asthma

• infection of lungs

• pain in the arms and/or legs

• lung disorders

• itchy rash

• back pain

• sleepiness (somnolence)

• neck pain

• haemorrhoids (swelling of blood vessels around the back passage)

• bone pain

• itchiness

• acne

• leg cramps

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

• deafness
• bumpy rash
• wheezing
• inflammation or scarring of the lungs

Rare side effects (may affect up to 1 in 1 000 people):

• jaundice (yellowing of the skin and the whites of the eyes)
• anaphylactic reactions (serious sudden allergic reaction with symptoms such as rash, itchy skin, difficulty breathing or feeling dizzy or faint)

Side effects of not known frequency ( frequency cannot be estimated from the available data):

• abnormal or impaired blood clotting
• high potassium levels
• swelling or bleeding at the back of the eyes
• shock (a dangerous decrease of blood pressure causing symptoms like rapid, shallow breathing, cold, clammy skin, a rapid, weak pulse, dizziness, weakness and fainting)
• abnormal heart rhythm
• respiratory distress
• respiratory failure
• acute accumulation of fluid in the lungs
• acute narrowing of the airways
• abnormally low oxygen levels in the blood
• difficulty in breathing when lying flat
• liver damage
• swelling of the face, lips and throat
• kidney failure
• abnormally low levels of fluid around baby in womb
• failure of lungs to develop in the womb
• abnormal kidney development in the womb

Some of the side effects you experience may be due to your underlying breast cancer. If you receive Ogivri in combination with chemotherapy, some of them may also be due to the chemotherapy.

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

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 and on the vial label after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2 C 8 C).

Infusion solutions should be used immediately after dilution. Do not use Ogivri if you notice any particulate matter or discoloration prior to administration.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Ogivri contains

• The active substance is trastuzumab. Each vial contains either; * 150 mg trastuzumab that has to be dissolved in 7.2 mL of water for injections, or * 420 mg trastuzumab that has to be dissolved in 20 mL of water for injections.
• The resulting solution contains approximately 21 mg/mL trastuzumab.
• The other ingredient(s) are L-histidine hydrochloride, L-histidine, sorbitol (E420 [see section 2 Ogivri contains sorbitol (E420) and sodium ]), macrogol 3350, hydrochloric acid and sodium hydroxide (for pH adjustment).

What Ogivri looks like and contents of the pack

Ogivri is a powder for concentrate for solution for intravenous infusion, which is supplied in a glass vial with a rubber stopper containing either 150 mg or 420 mg of trastuzumab. The powder is a white to pale yellow pellet. Each carton contains 1 vial of powder.

Marketing Authorisation Holder

Biosimilar Collaborations Ireland Limited Unit 35/Grange Parade, Baldoyle Industrial Estate, Dublin DUBLIN Ireland
D13 R20R

Manufacturer

Biosimilar Collaborations Ireland Limited Block B, The Crescent Building, Santry Demesne Dublin D09 C6X8

Ireland

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Biocon Biologics Belgium BV T l/Tel: 0080008250Lietuva Biosimilar Collaborations Ireland Limited Tel: 0080008250
Biosimilar Collaborations Ireland Limited : 0080008250Luxembourg/Luxemburg Biocon Biologics France S.A.S T l/Tel: 0080008250 esk republika Biocon Biologics Germany GmbH
Tel: 0080008250Magyarorsz g Biosimilar Collaborations Ireland Limited
Tel.: 0080008250Danmark Biocon Biologics Finland OY
Tlf: 0080008250Malta Biosimilar Collaborations Ireland Limited
Tel.: 0080008250Deutschland Biocon Biologics Germany GmbH
Tel: 0080008250Nederland Biocon Biologics France S.A.S Tel: 0080008250Eesti Biosimilar Collaborations Ireland Limited Tel: 0080008250Norge Biocon Biologics Finland OY
Tlf: +47 800 62
Biocon Biologics Greece
. .
.: 0080008250 sterreich Biocon Biologics Germany GmbH Tel: 0080008250Espa a Biocon Biologics Spain S.L. Tel: 0080008250Polska Biosimilar Collaborations Ireland Limited
Tel: 0080008250France Biocon Biologics France S.A.S
Tel: 0080008250Portugal Biocon Biologics Spain S.L. Tel: 0080008250Hrvatska Biocon Biologics Germany GmbH
Tel: 0080008250Rom nia Biosimilar Collaborations Ireland Limited
Tel: 0080008250Ireland Biosimilar Collaborations Ireland Limited
Tel: 1800 777 Slovenija Biosimilar Collaborations Ireland Limited
Tel: 0080008250 sland Biocon Biologics Finland OY
S mi: +345 8004Slovensk republika Biocon Biologics Germany GmbH
Tel: 0080008250Italia Biocon Biologics Spain S.L. Tel: 0080008250Suomi/Finland Biocon Biologics Finland OY
Puh/Tel: 99980008250
Biosimilar Collaborations Ireland Limited
: 0080008250Sverige Biocon Biologics Finland OY
Tel: 0080008250Latvija Biosimilar Collaborations Ireland Limited
Tel: 0080008250This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: ..