WARNING

While Ogivri (trastuzumab) is generally considered safe and well-tolerated, like any medication, it carries certain risks. It’s important to note that the following information provides a general overview, and specific risks can vary depending on individual factors and the overall treatment plan. It is essential to consult with a healthcare professional for personalized information and guidance.

• Infusion-related reactions: When receiving Ogivri intravenously, some individuals may experience infusion-related reactions such as fever, chills, nausea, vomiting, headache, allergic reactions, or difficulty breathing. These reactions can range from mild to severe. Medications are often administered before treatment to help prevent or minimize these reactions.
• Cardiac toxicity: Trastuzumab, the active ingredient in Ogivri, can affect the heart’s function and potentially lead to cardiac problems, including congestive heart failure or reduced heart function. Before starting treatment, patients may undergo cardiac evaluations to assess their heart’s health and determine the suitability of Ogivri.
• Reduced blood cell counts: Ogivri can cause a decrease in various types of blood cells, including white blood cells, red blood cells, and platelets. This may increase the risk of infections, anemia, or bleeding. Regular blood tests are typically performed to monitor these levels during treatment.
• Pulmonary toxicity: In rare cases, trastuzumab has been associated with pulmonary toxicity, leading to lung problems such as interstitial pneumonitis or pulmonary fibrosis. Symptoms may include cough, shortness of breath, or difficulty breathing.
• Increased risk of infections: As trastuzumab affects the immune system, it may increase the risk of developing infections. Patients should promptly report any signs of infection, such as fever, sore throat, or persistent cough, to their healthcare provider.
• Potential harm to developing fetuses: Ogivri can harm unborn babies, so it is not recommended for use during pregnancy. Adequate contraception should be used during treatment and for a period after its completion.

It’s crucial to understand that the risks and benefits of Ogivri should be carefully considered in the context of an individual’s specific medical condition. Healthcare professionals closely monitor patients receiving Ogivri and take appropriate measures to manage and minimize potential risks. If you have been prescribed Ogivri, discuss any concerns or questions you may have with your healthcare provider for a comprehensive understanding of its risks and benefits in your situation.

Why is this medication prescribed?

Ogivri is a prescription medication that contains the active ingredient trastuzumab, which is a monoclonal antibody. It is prescribed for the treatment of certain types of cancer, specifically HER2-positive breast cancer and metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma).

HER2-positive breast cancer refers to a specific type of breast cancer where the cancer cells have an overexpression of a protein called human epidermal growth factor receptor 2 (HER2). This overexpression leads to uncontrolled cell growth and proliferation. Trastuzumab, the active ingredient in Ogivri, specifically targets and binds to the HER2 protein on the cancer cells, inhibiting its function and slowing down the growth of the cancer.

Ogivri is prescribed in combination with other chemotherapy drugs for the treatment of early-stage HER2-positive breast cancer after surgery or as a neoadjuvant treatment (before surgery) to shrink tumors. In the case of metastatic stomach cancer, it is used in combination with chemotherapy for patients who have not received prior treatment for their advanced cancer.

How should this medicine be used?

Ogivri (trastuzumab) is typically administered as an intravenous (IV) infusion, meaning it is given directly into a vein. The dosage and treatment schedule may vary depending on the specific type of cancer being treated and the individual patient’s condition. It’s important to follow the instructions provided by your healthcare professional. Here is a general overview of how Ogivri is commonly used:

• Administration: Ogivri is administered by a healthcare professional in a hospital or clinic setting. It is given as an IV infusion over a specified period of time. The infusion may take about 30 minutes to several hours, depending on the dose and individual factors.
• Treatment duration: The duration of Ogivri treatment can vary. It may be given as a short-term treatment, such as in the neoadjuvant setting before surgery, or as a long-term treatment for metastatic or advanced cancers. The treatment plan is determined by your healthcare provider based on the specific cancer type, stage, and individual response to treatment.
• Combination therapy: Ogivri is often used in combination with other chemotherapy drugs for more effective cancer treatment. The specific combination and dosages will be determined by your healthcare provider.
• Monitoring and follow-up: Throughout the course of treatment, your healthcare provider will closely monitor your progress. Regular medical check-ups, blood tests, and imaging studies may be performed to assess the response to treatment, monitor side effects, and make any necessary adjustments to the treatment plan.

It’s important to adhere to the prescribed treatment schedule and attend all follow-up appointments. If you have any questions or concerns about the administration or usage of Ogivri, it’s essential to consult your healthcare provider, who can provide detailed instructions and address any specific considerations based on your medical condition.

Other uses for this medicine

Ogivri (trastuzumab) is primarily used for the treatment of HER2-positive breast cancer and metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma). However, it’s worth noting that trastuzumab, the active ingredient in Ogivri, may also be used off-label for other types of cancers that overexpress the HER2 protein, such as HER2-positive metastatic colorectal cancer or HER2-positive metastatic bladder cancer. Off-label use refers to the use of a medication for a condition that has not received official approval by regulatory authorities.

What special precautions should I follow?

As for special precautions, there are several important considerations when using Ogivri:

• Heart function monitoring: Ogivri can potentially affect the heart, leading to cardiac problems such as congestive heart failure or reduced heart function. Before initiating treatment, a thorough evaluation of cardiac function may be conducted, which can include tests like echocardiograms or measurement of the heart’s ejection fraction. Regular monitoring of cardiac function may be performed during treatment to ensure the heart remains healthy.
• Infusion-related reactions: Ogivri is administered intravenously, and infusion-related reactions are possible. These reactions may include symptoms like fever, chills, nausea, vomiting, headache, allergic reactions, or breathing difficulties. Pre-medications are often given to help reduce the risk and severity of these reactions. Healthcare professionals closely monitor patients during the infusion and are prepared to manage any reactions that may occur.
• Pregnancy and breastfeeding: Ogivri can potentially harm unborn babies, so it is generally not recommended for use during pregnancy. Adequate contraception should be used during treatment and for a period of time after completion. It is also not known if Ogivri passes into breast milk, so breastfeeding is generally not recommended during treatment.
• Pre-existing lung conditions: Ogivri may cause pulmonary toxicity, resulting in lung problems such as interstitial pneumonitis or pulmonary fibrosis. Patients with pre-existing lung conditions may be at a higher risk. Symptoms such as cough, shortness of breath, or difficulty breathing should be promptly reported to the healthcare provider.
• Infections: Ogivri can affect the immune system, potentially increasing the risk of infections. Patients should promptly report any signs of infection, such as fever, sore throat, or persistent cough, to their healthcare provider.

These are some general precautions associated with the use of Ogivri, but it’s important to note that individual circumstances may vary. Therefore, it’s essential to consult with a healthcare professional who can provide personalized guidance based on your specific medical condition and treatment plan.

What special dietary instructions should I follow?

There are no specific dietary instructions associated with Ogivri (trastuzumab) use. However, it’s generally important to maintain a healthy and balanced diet during cancer treatment to support overall well-being and provide adequate nutrition. Your healthcare provider or a registered dietitian can provide personalized guidance on diet and nutrition based on your specific needs.

What should I do if I forget a dose?

If you forget a dose of Ogivri, it’s crucial to contact your healthcare provider or treatment team as soon as possible for guidance. Missing a dose may impact the effectiveness of the treatment, so it’s important to follow the recommended treatment schedule. Your healthcare provider will advise you on the best course of action based on the timing and circumstances of the missed dose. It’s generally not recommended to double the dose or make any changes to the treatment plan without medical guidance.

What side effects can this medication cause?

Ogivri (trastuzumab) can cause various side effects, although not everyone experiences them. Side effects can vary in severity and may differ from person to person. It’s important to note that the following list is not exhaustive, and you should consult your healthcare provider for a comprehensive understanding of potential side effects. Some common side effects of Ogivri include:

• Infusion-related reactions: During or shortly after the infusion, some individuals may experience symptoms such as fever, chills, nausea, vomiting, headache, allergic reactions, or difficulty breathing. Pre-medications are often administered to help prevent or minimize these reactions.
• Cardiac toxicity: Ogivri may affect the heart’s function, potentially leading to cardiac problems, including congestive heart failure or reduced heart function. Regular monitoring of cardiac function, such as echocardiograms or measuring the heart’s ejection fraction, may be performed during treatment.
• Reduced blood cell counts: Ogivri can cause a decrease in various types of blood cells, including white blood cells, red blood cells, and platelets. This may increase the risk of infections, anemia, or bleeding.
• Fatigue: Feeling tired or experiencing fatigue is a common side effect of cancer treatment, including Ogivri.
• Diarrhea: Some individuals may experience diarrhea as a side effect of Ogivri treatment. It’s important to stay hydrated and report severe or persistent diarrhea to your healthcare provider.
• Nausea and vomiting: Ogivri can cause nausea and vomiting. Medications may be prescribed to help manage these symptoms.
• Skin rash: Some patients may develop a skin rash or experience itching as a side effect of Ogivri. Inform your healthcare provider if you notice any skin changes.
• Headache: Headaches can occur as a side effect of Ogivri treatment, although they are generally mild.
• Musculoskeletal pain: Some individuals may experience muscle or joint pain during treatment.
• Infections: Ogivri can affect the immune system, potentially increasing the risk of infections. Promptly report any signs of infection, such as fever, sore throat, or persistent cough, to your healthcare provider.

It’s important to communicate with your healthcare provider about any side effects you experience during Ogivri treatment. They can provide guidance, offer supportive care, and make any necessary adjustments to manage side effects effectively.

What should I know about storage and disposal of this medication?

Storage and disposal: Ogivri should be stored in a refrigerator between 2°C and 8°C (36°F and 46°F). Do not freeze the medication. Keep it in its original packaging until ready for use. If necessary, your healthcare provider or pharmacist can provide specific instructions for proper storage.

Disposal of unused or expired Ogivri should be done in accordance with local regulations and guidelines. It’s recommended to consult with your healthcare provider, pharmacist, or local waste management authorities for appropriate disposal methods.

In case of emergency/overdose

In case of an emergency or suspected overdose, immediately contact your local emergency services or go to the nearest emergency room. It’s important to have the packaging or labeling of the medication readily available for healthcare professionals to assess the situation accurately.

What other information should I know?

• Medication Interactions: Inform your healthcare provider about all the medications, supplements, or herbal products you are taking, as they may interact with Ogivri. Certain medications, such as anthracyclines or other cardiotoxic drugs, may increase the risk of heart-related side effects when used concomitantly with Ogivri.
• Regular Monitoring: Your healthcare provider will closely monitor your progress during treatment with Ogivri. This includes regular medical check-ups, cardiac assessments, blood tests, and imaging studies to evaluate the response to treatment and manage any potential side effects.
• Pregnancy and Breastfeeding: Ogivri may harm unborn babies, so it is generally not recommended during pregnancy. Adequate contraception should be used during treatment and for a period of time after completion. It is also not known if Ogivri passes into breast milk, so breastfeeding is generally not recommended during treatment.
• Follow-up Care: It’s important to adhere to the recommended treatment schedule and attend all follow-up appointments with your healthcare provider. They will provide guidance on the duration of treatment and any necessary adjustments to the regimen based on your response and overall condition.
• Emotional Support: Dealing with cancer and its treatment can be emotionally challenging. Consider seeking emotional support from friends, family, support groups, or counseling services to help cope with the emotional impact of the journey.

Remember, the information provided here is a general overview, and specific instructions or recommendations may vary depending on individual circumstances. Always consult your healthcare provider or oncology team for personalized information and guidance regarding the storage, disposal, emergency procedures, and any other relevant aspects of your Ogivri treatment.