Prospect: Information for the user

Ogivri 150 mg powder for concentrate for solution for infusion

Ogivri 420 mg powder for concentrate for solution for infusion

trastuzumab

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

– Keep this prospect, as you may need to read it again.

– If you have any questions, consult your doctor, pharmacist, or nurse.

–If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

1. What is Ogivri and for what it is used

2. What you need to know before starting to use Ogivri

3. How to use Ogivri

4. Possible adverse effects

5. Storage of Ogivri

6. Contents of the package and additional information

Ogivri contains trastuzumab as its active substance, which is a monoclonal antibody. Monoclonal antibodies specifically recognize proteins or antigens. Trastuzumab is designed to selectively bind to an antigen called the human epidermal growth factor receptor 2 (HER2). The HER2 is found in large quantities on the surface of some cancer cells and stimulates the growth of these cells. When Ogivri binds to the HER2, it slows down the growth of these cells, causing them to die.

Your doctor may prescribe Ogivri for the treatment of breast or stomach cancer when:

• You have early-stage breast cancer with high levels of a protein called HER2.

•You have metastatic breast cancer (breast cancer in which the original tumor has spread) with high levels of HER2. Ogivri may be prescribed in combination with the chemotherapy medications paclitaxel or docetaxel as first-line treatment for metastatic breast cancer or it may be prescribed alone if other treatments have not been successful. It is also used in combination with other medications called aromatase inhibitors in 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 stomach cancer with high levels of HER2, and it is combined with other cancer medications such as capecitabina or 5-fluorouracilo and cisplatino.

No use Ogivri:

• If you are allergic to trastuzumab, mouse proteins, or any of the other components of this medication (listed in section 6).
• If you have severe respiratory problems at rest due to your tumor or if you need oxygen treatment.

Advertencias y precauciones

Your doctor will closely monitor your treatment.

Cardiac reviews

Treatment with Ogivri alone or in combination with a taxane may affect the heart, especially if you have ever received an anthracycline (taxanes and anthracyclines are two types of medications used to treat cancer).

The effects can be moderate to severe and may be fatal. Therefore, you should have your cardiac function 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 blood pumping by the heart), your doctor will check how your heart is functioning more frequently (every six to eight weeks), you may receive treatment for heart failure, or you may need to discontinue treatment with Ogivri.

Consult your doctor, pharmacist, or nurse before receiving Ogivri if:

•You have had heart failure, coronary artery disease, heart valve disease (heart murmur) or high blood pressure, have taken any medication for high blood pressure, or are currently taking any medication for high blood pressure.

•You have ever received or are currently receiving a medication called doxorubicin or epirubicin (cancer medications). These medications (or any other anthracycline) may damage the heart muscle and increase the risk of heart problems when treated with Ogivri.

•You feel short of breath, especially if you are currently receiving a taxane. Ogivri may cause breathing difficulties, especially when administered for the first time. This may be more severe if you already have shortness of breath. In very rare cases, patients with severe breathing difficulties before treatment have died when given Ogivri.

• You have ever had any other cancer treatment.

If you receive Ogivri with any other medication for cancer such as paclitaxel, docetaxel, an aromatase inhibitor, capecitabine, 5-fluorouracil, or cisplatin, you should also read the prospectuses for these medications.

Children and adolescents

Ogivri is not recommended for individuals under 18 years.

Other medications and Ogivri

Inform your doctor, pharmacist, or nurse if you are using, have used recently, or may need to use any other medication.

Ogivri may take up to 7 months to be completely eliminated from the body. Therefore, if you are to take any new medication within 7 months of completing treatment, you should inform your doctor, pharmacist, or nurse that you have been treated with Ogivri.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor, pharmacist, or nurse before using this medication.

Pregnancy

•You must use an effective contraceptive method during treatment with Ogivri and for at least 7 months after completing treatment.

•Your doctor will explain the risks and benefits of taking Ogivri during pregnancy. In rare cases, a decrease in the fluid surrounding the developing fetus in the womb (amniotic fluid) has been observed in pregnant women given trastuzumab. This may be harmful to the fetus and has been associated with underdeveloped lungs resulting in fetal death.

Breastfeeding

You should not breastfeed your baby during Ogivri therapy and for up to 7 months after the last dose of Ogivri, as this medication may reach your baby through breast milk. Consult your doctor or pharmacist before taking any medication.

Driving and operating machinery

Ogivri may affect your ability to drive a vehicle or operate machinery. If you experience symptoms during treatment, such as dizziness, drowsiness, chills, or fever, you should not drive or use machinery until these symptoms have resolved.

Ogivri contains sorbitol (E-420) and sodium

Ogivri 150 mg powder for concentrate for solution for infusion

This medication contains 115.2 mg of sorbitol in each vial.

Ogivri 420 mg powder for concentrate for solution for infusion

This medication contains 322.6 mg of sorbitol in each vial.

Sorbitol is a source of fructose. If you have hereditary fructose intolerance (HFI), a rare genetic disorder, you should not receive this medication. HFI patients cannot break down fructose, which may cause severe adverse effects. Consult your doctor before receiving this medication if you have HFI or cannot consume sweet foods or drinks because they cause dizziness, vomiting, or unpleasant effects such as bloating, stomach cramps, or diarrhea.

Ogivri contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

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

The first dose of your treatment is administered over 90 minutes and will be monitored by a healthcare professional while it is being administered, in case any adverse reactions occur. If the initial dose has been well tolerated, subsequent doses may be administered in 30 minutes (see section 2 “Warnings and Precautions”). The number of infusions you can receive will depend on your response to treatment. Your doctor will inform you about this.

Ogivri is administered as an intravenous infusion in a vein (intravenous infusion, drip), this intravenous formulation is not for subcutaneous administration and should only be administered as an intravenous infusion.

For early breast cancer, metastatic breast cancer, and metastatic gastric cancer, Ogivri will be administered every 3 weeks. Ogivri can also be administered once a week for metastatic breast cancer.

To avoid medication errors, it is essential to check the labels on the vials to ensure that the medication being prepared and administered is Ogivri (trastuzumab) and not another product that contains trastuzumab (e.g., trastuzumab emtansina or trastuzumab deruxtecan).

If You Interrupt Treatment with Ogivri

Do not stop treatment with this medication without first talking to your doctor. All doses must be taken at the right time, either weekly or every 3 weeks (depending on your dosing schedule). This helps your medication work properly.

It may take up to 7 months for Ogivri to be completely eliminated from the body. Therefore, your doctor may decide to continue monitoring your heart function even after you have completed treatment.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Some of these side effects can be serious and require hospitalization.

During the administration of an Ogivri infusion, chills, fever, and other symptoms similar to the flu may occur. This is very common (can affect more than 1 in 10 people). Other symptoms related to the infusion are: feeling unwell (nausea), vomiting, pain, muscle tension, agitation, headache, dizziness, shortness of breath, decreased or increased blood pressure, heart rhythm disturbances (palpitations, arrhythmias, or irregular heartbeat), facial and lip swelling, rash, and feeling tired. Some of these symptoms can be serious and some patients have died (see section 2 "Warnings and precautions").

These side effects mainly occur during the first intravenous infusion ("drip" in vein) and during the first hours after the start of the infusion. They are usually transient. A healthcare professional will monitor you during the infusion and, for at least six hours, after the start of the first infusion and during two hours after the start of the rest of the infusions. If you have any reaction, they may be able to administer the infusion more slowly or interrupt the infusion and give you a treatment to counteract the side effects. The infusion can continue once your symptoms have improved.

Occasionally, symptoms start after 6 hours after the start of the infusion. If this happens to you, contact your doctor immediately. Sometimes, symptoms can improve and worsen later.

Severe side effects

Other side effects may occur at any time during treatment with Ogivri and are not related to the infusion.

Inform your doctor or nurse if you experience any of the following side effects:

• Occasionally, heart problems can occur during treatment and, occasionally, after stopping treatment, and these can be serious. These include, heart muscle weakness, which may cause heart failure, inflammation of the heart's outer layer, and heart rhythm disturbances. This can cause symptoms such as shortness of breath (even at night), cough, fluid retention (swelling) in the legs or arms, palpitations (arrhythmias or irregular heartbeat) (see section 2 "Cardiac reviews"). Your doctor will monitor your heart periodically during and after treatment, but you should inform your doctor immediately if you notice any of the described symptoms.

• The tumor lysis syndrome (a 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 can include kidney problems (weakness, shortness of breath, fatigue, and confusion), heart problems (palpitations or a faster or slower heart rate), seizures, vomiting, or diarrhea, and tingling in the mouth, hands, or feet.

If you experience any of these symptoms after your treatment with Ogivri has ended, you should consult your doctor and inform them that you have been previously treated with Ogivri.

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

• infections
• diarrhea
• constipation
• heartburn (dyspepsia)
• fatigue
• weakness
• skin rash
• chest pain
• abdominal pain (stomach)
• joint pain
• low white blood cell and red blood cell count (which help fight infection), sometimes with fever
• muscle pain
• conjunctivitis (discharge with itching of the eyes and eyelids, with a scaly appearance)
• tearing
• nasal bleeding
• nasal discharge
• hair loss
• tremors
• headaches
• dizziness
• changes in nails
• weight loss
• loss of appetite
• difficulty sleeping (insomnia)
• change in taste
• low platelet count
• cardinal signs
• numbness or tingling in the hands and feet, which, occasionally, can extend to the rest of the extremity
• redness, swelling, or ulcers in the mouth and/or throat
• pain, swelling, redness, or tingling in the hands and/or feet
• difficulty breathing
• headache
• cough
• vomiting
• nausea (feeling unwell)

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

• allergic reactions
• dry mouth and skin
• throat infections
• dry eyes
• urinary and skin infections
• sweating
• feeling weak and unwell
• breast inflammation
• anxiety
• liver inflammation
• depression
• kidney problems
• increased muscle tone or tension (hypertonia)
• asthma
• lung infections
• arm and/or leg pain
• pulmonary changes
• skin rash with itching
• back pain
• feeling sleepy (somnolence)
• neck pain
• hemorrhoids (inflammation of the blood vessels around the anus)
• bone pain
• itching
• acne
• leg cramps

Rare side effects(can affect up to 1 in 100 people):

• hearing loss
• skin rash with blisters
• breathing sounds (whistling)
• inflammation/cicatrisation of the lungs

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

• jaundice (yellow color in the skin and white part of the eyes)
• anaphylactic reactions (severe allergic reaction, with symptoms such as rash, itching, difficulty breathing, or feeling dizzy or faint)

Side effects of unknown frequency(cannot be estimated from available data):

• abnormal blood coagulation or coagulation insufficiency
• high potassium levels
• inflammation or hemorrhages in the back of the eyes
• shock (a dangerous drop in blood pressure, which can cause symptoms such as rapid and shallow breathing, cold, sweaty skin, a weak and rapid pulse, dizziness, weakness, and fainting)
• inflammation of the heart's outer layer
• difficulty breathing
• respiratory insufficiency
• acute accumulation of fluid in the lungs
• acute narrowing of the airways
• abnormally low oxygen levels in the blood
• difficulty breathing while lying down
• liver damage
• inflammation of the face, lips, and throat
• renal failure
• abnormally low levels of fluid surrounding the fetus in the womb
• failure of the lungs to develop in the fetus
• abnormal development of the kidneys in the fetus

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

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the vial label after CAD or EXP. The expiration date is the last day of the month indicated.

Store in refrigerator (between 2 °C and 8 °C).

Infusion solutions must be used immediately after dilution. Do not use Ogivri if you observe any foreign particles or discoloration before administration.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Ogivri

–The active ingredient is trastuzumab. Each vial contains:

• 150 mg of trastuzumab that dissolves in 7.2 ml of water for injectable preparations or
• 420 mg of trastuzumab that dissolves in 20 ml of water for injectable preparations.

–The resulting solution contains approximately 21 mg/ml of trastuzumab.

–The other components are L-histidine hydrochloride, L-histidine, sorbitol (E-420)

(see section 2 “Ogivri contains sorbitol (E-420) and sodium”), macrogol 3350, hydrochloric acid and sodium hydroxide (for pH adjustment).

Appearance of the product and contents of the pack

Ogivri is a lyophilized powder for concentrate for solution for intravenous infusion, presented in a glass vial with a rubber stopper and containing 150 mg or 420 mg of trastuzumab. It is a white to pale yellow lyophilized pellet powder. Each pack contains 1 vial of powder.

Marketing Authorization Holder

Biosimilar Collaborations Ireland Limited

Unit 35/36

Grange Parade,

Baldoyle Industrial Estate,

Dublin 13

DUBLIN

Ireland

D13 R20R

Manufacturer

Biosimilar Collaborations Ireland Limited

Block B, The Crescent Building, Santry Demesne

Dublin

D09 C6X8

Ireland

For further information about this medicinal product, please consult the representative of the marketing authorization holder in your country:

Last update of this leaflet: 11/2024

For detailed information about this medicinal product, please consult the website of the European Medicines Agency:http://www.ema.europa.euand the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).

This information is intended for healthcare professionals only

To avoid medication errors, it is essential to check the labels on the vials to ensure that the medication being prepared and administered is Ogivri (trastuzumab) and not another product containing trastuzumab (e.g., trastuzumab emtansine or trastuzumab deruxtecan).

Keep this medicinal product in its original packaging, closed, at a temperature of between 2 °C - 8 °C in a refrigerator. The reconstituted vial of Ogivri with water for injectable preparations (not supplied in the packaging) is stable for 10 days in a temperature range of between 2 °C - 8 °C after reconstitution and should not be frozen.

Ogivri should be handled carefully during reconstitution. If excessive foam forms during reconstitution or Ogivri reconstituted is agitated, it may cause problems with the amount of Ogivri that can be withdrawn from the vial.

Ogivri 150 mg powder for concentrate for solution for infusion

Aseptic technique should be used. Each 150 ml vial of Ogivri is reconstituted with 7.2 ml of sterile water for injectable preparations (not supplied). Other reconstitution solvents should not be used. This produces a 7.4 ml single-dose solution containing approximately 21 mg/ml of trastuzumab. A 4% overfill allows the 150 mg dose reflected on the label to be withdrawn from each vial.

Ogivri 420 mg powder for concentrate for solution for infusion

Aseptic technique should be used. Each 420 mg vial of Ogivri is reconstituted with 20 ml of sterile water for injectable preparations (not supplied in the packaging). Other reconstitution solvents should not be used. This produces a 21 ml single-dose solution containing approximately 21 mg/ml of trastuzumab. A 4.8% overfill allows the 420 mg dose reflected on the label to be withdrawn from each vial.

Instructions for reconstitution

1. Using a sterile syringe, slowly inject the appropriate volume (as indicated above) of water for injectable preparations into the vial containing the Ogivri lyophilisate, directing the flow towards the lyophilisate.
2. Mix the vial gently to help reconstitution. DO NOT SHAKE!

A slight foam formation after reconstitution is usual. Leave the vial at rest for approximately 5 minutes. The reconstituted Ogivri is a clear, colorless to pale yellow solution and should be essentially free of visible particles.

The required solution volume will be determined:

• Based on the initial dose of 4 mg of trastuzumab/kg of body weight or subsequent weekly doses of 2 mg of trastuzumab/kg of body weight:

• Based on the initial dose of 8 mg of trastuzumab/kg of body weight or subsequent doses every 3 weeks of 6 mg of trastuzumab/kg of body weight:

The appropriate solution volume should be withdrawn from the vial using a sterile syringe and needle and added to a polyvinyl chloride, polyethylene or polypropylene infusion bag containing a 250 ml solution of sodium chloride, 9 mg/ml (0.9%) for injection. Do not use with solutions containing glucose. The bag should be gently inverted to mix the solution and prevent foam formation. Parenteral solutions should be visually inspected for particles and discoloration before administration. Once the infusion is prepared, it should be administered immediately. If diluted aseptically, it can be stored for up to 90 days at 2 °C - 8 °C and 24 hours at temperatures not exceeding 30 °C.