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Tepezza (Generic Teprotumumab-trbw Injection)

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Why is this medication prescribed?

Tepezza (teprotumumab) is a medication primarily prescribed for the treatment of thyroid eye disease (TED), also known as Graves’ ophthalmopathy. TED is an autoimmune condition where the muscles and tissues around the eyes become inflamed, causing symptoms such as eye pain, swelling, redness, double vision, and in severe cases, vision loss. Tepezza works by targeting insulin-like growth factor 1 receptor (IGF-1R), which is believed to play a role in the development of TED.

How should this medicine be used?

Tepezza (teprotumumab) is typically administered as an intravenous infusion by a healthcare professional in a clinical setting, such as a hospital or infusion center. Here are some general guidelines on how Tepezza is used:

  • Administration: Tepezza is given as an intravenous (IV) infusion, meaning it is injected directly into a vein. It is not available in oral or topical forms.
  • Dosage: The dosage of Tepezza and the frequency of administration are determined by a healthcare provider based on factors such as the severity of thyroid eye disease (TED), the patient’s response to treatment, and any underlying health conditions.
  • Treatment schedule: Tepezza treatment typically involves a series of eight infusions given every three weeks. This treatment schedule may vary depending on individual patient factors and the healthcare provider’s recommendations.
  • Monitoring: During Tepezza infusion, patients are usually monitored for any adverse reactions or side effects. Healthcare providers will closely monitor vital signs and may perform other assessments as needed.
  • Duration of treatment: The entire course of Tepezza treatment lasts approximately 24 weeks (about 6 months), with infusions administered every three weeks. It’s essential for patients to complete the full course of treatment as prescribed by their healthcare provider.
  • Follow-up: After completing the Tepezza treatment course, patients may require follow-up appointments with their healthcare provider to monitor their TED symptoms and overall health. Additional treatments or interventions may be recommended based on the individual’s response to Tepezza.

It’s crucial for patients to follow their healthcare provider’s instructions closely regarding Tepezza administration and to attend all scheduled appointments for monitoring and follow-up. Any questions or concerns about Tepezza treatment should be discussed with a healthcare provider.

Other uses for this medicine

Tepezza (teprotumumab) is specifically approved for the treatment of thyroid eye disease (TED) and does not have other approved uses. However, it’s important to consult with a healthcare provider or a medical professional for the most current and accurate information regarding any potential off-label uses of Tepezza.

What special precautions should I follow?

Regarding special precautions for Tepezza, here are some important considerations:

  • Allergic reactions: Inform your healthcare provider about any known allergies or sensitivities to medications, including Tepezza or any of its components. Allergic reactions to Tepezza may occur and can range from mild to severe.
  • Pregnancy and breastfeeding: It is essential to discuss the risks and benefits of Tepezza treatment if you are pregnant, planning to become pregnant, or breastfeeding. The safety of Tepezza during pregnancy and breastfeeding has not been established, and healthcare providers will weigh the potential risks to the fetus or infant against the potential benefits of treatment.
  • Pre-existing conditions: Inform your healthcare provider about any pre-existing medical conditions you may have, such as heart disease, diabetes, or any autoimmune disorders, as these may influence the suitability of Tepezza treatment or require special monitoring.
  • Medication interactions: Provide a complete list of all medications, supplements, and herbal products you are currently taking to your healthcare provider, as Tepezza may interact with other drugs. This includes over-the-counter medications and dietary supplements.
  • Infusion reactions: Tepezza is administered intravenously, and infusion reactions such as fever, chills, nausea, headache, or rash may occur during or after the infusion. Healthcare providers typically monitor patients closely for these reactions and may provide supportive care as needed.
  • Ophthalmic effects: Tepezza treatment may lead to ocular adverse reactions, including worsening of vision, eye pain, and inflammation. It’s essential to report any new or worsening eye symptoms to your healthcare provider promptly.
  • Immunosuppression: Tepezza may affect the immune system, potentially increasing the risk of infections. Inform your healthcare provider if you develop signs or symptoms of infection during Tepezza treatment.

Always follow your healthcare provider’s instructions and recommendations regarding Tepezza treatment, including any special precautions or monitoring requirements. If you have any questions or concerns about Tepezza or its use, don’t hesitate to discuss them with your healthcare provider.

What special dietary instructions should I follow?

There are no specific dietary instructions associated with Tepezza. However, maintaining a healthy and balanced diet is generally recommended to support overall health and well-being.

What should I do if I forget a dose?

If you miss a scheduled dose of Tepezza, contact your healthcare provider as soon as possible to reschedule the missed dose. It’s important to complete the full course of treatment as prescribed to achieve the best possible outcomes. Avoid doubling the dose to make up for a missed one unless specifically instructed by your healthcare provider.

What side effects can this medication cause?

Tepezza (teprotumumab) can cause various side effects, ranging from mild to severe. Not all individuals will experience these side effects, and the severity and frequency may vary from person to person. Some common side effects of Tepezza include:

  • Muscle spasms or weakness
  • Nausea
  • Diarrhea
  • Fatigue
  • Headache
  • Insomnia
  • Swelling or edema (especially in the hands and feet)
  • Increased blood sugar levels (hyperglycemia)
  • High blood pressure (hypertension)
  • Increased levels of liver enzymes

In addition to these common side effects, Tepezza may also cause more serious adverse reactions, including:

  • Infusion reactions: Some individuals may experience infusion reactions during or shortly after receiving Tepezza. Symptoms may include fever, chills, nausea, headache, rash, or difficulty breathing. These reactions typically require immediate medical attention.
  • Ocular effects: Tepezza treatment may lead to ocular adverse reactions, such as worsening of vision, eye pain, dry eyes, and inflammation of the cornea (keratitis). Patients should report any new or worsening eye symptoms to their healthcare provider promptly.
  • Immune system effects: Tepezza may affect the immune system, potentially increasing the risk of infections. Patients should be vigilant for signs and symptoms of infection and notify their healthcare provider if they develop any.
  • Blood sugar control: Tepezza may affect blood sugar levels, particularly in individuals with diabetes or pre-existing glucose metabolism disorders. Monitoring of blood sugar levels may be necessary during treatment.
  • Thyroid function: Tepezza may interfere with thyroid function tests, leading to inaccurate results. Healthcare providers should be aware of this potential effect when interpreting thyroid function test results in patients receiving Tepezza.

It’s essential for patients to discuss any concerns or side effects with their healthcare provider promptly. Additionally, healthcare providers will monitor patients closely for adverse reactions during Tepezza treatment and may adjust the dosage or provide supportive care as needed.

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

Storage and Disposal:

  • Storage: Tepezza vials should be stored refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until time of use. Do not freeze or shake the vials. Once diluted, the solution should be used immediately or stored under refrigeration at 2°C to 8°C (36°F to 46°F) for up to 24 hours.
  • Disposal: Dispose of any unused or expired Tepezza vials according to local regulations or guidelines. Do not dispose of medications via wastewater or household waste unless specifically instructed to do so.

In case of emergency/overdose

In case of emergency or overdose, it is important to seek immediate medical assistance or contact a poison control center. The National Poison Control Center hotline in the United States is 1-800-222-1222. Be prepared to provide information such as the amount of Tepezza ingested and any symptoms experienced.

What other information should I know?

  • Administration: Tepezza is administered by a healthcare professional as an intravenous infusion. Do not attempt to administer Tepezza on your own.
  • Monitoring: Your healthcare provider will monitor you closely during and after Tepezza infusion for any adverse reactions or side effects. Inform your healthcare provider of any new or worsening symptoms experienced during treatment.
  • Follow-Up: Attend all scheduled follow-up appointments with your healthcare provider to monitor your response to Tepezza treatment and to assess any ongoing management needs.
  • Additional Information: Discuss any questions or concerns you have about Tepezza with your healthcare provider. They can provide you with personalized information and guidance based on your individual health status and treatment plan.

Always follow your healthcare provider’s instructions regarding the storage, administration, and disposal of Tepezza. If you have any questions or require further clarification, don’t hesitate to reach out to your healthcare provider or pharmacist.

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