Why is this medication prescribed?

Berinert is a medication prescribed primarily for the treatment of hereditary angioedema (HAE). Hereditary angioedema is a rare genetic disorder characterized by recurrent episodes of severe swelling, typically in the face, limbs, airway, and intestinal tract. This swelling can be painful and potentially life-threatening if it affects the airway and leads to difficulty breathing.

Berinert is a C1 esterase inhibitor, which works by replenishing the deficient or malfunctioning C1 esterase inhibitor protein in individuals with HAE. This helps to regulate certain pathways in the body that control inflammation and prevent excessive swelling during HAE attacks.

How should this medicine be used?

Berinert is typically administered as an intravenous (IV) infusion by a healthcare professional. Here’s how it’s usually used:

• Dosage: The dosage of Berinert varies depending on the individual’s weight, the severity of the attack, and other factors determined by the healthcare provider.
• Administration: Berinert is administered through a vein, usually in the arm. Healthcare professionals will prepare the medication and administer it according to the prescribed dosage.
• Preparation: Before administration, the healthcare provider will check the medication for any signs of damage or discoloration. Berinert is typically supplied as a lyophilized powder that needs to be reconstituted with a diluent provided with the medication. The reconstituted solution should be clear and colorless.
• Infusion: The reconstituted Berinert solution is then slowly infused into the vein over a period of time specified by the healthcare provider. The rate of infusion may vary depending on the individual’s tolerance and the severity of the attack.
• Monitoring: During and after the infusion, the healthcare provider will monitor the individual for any adverse reactions or signs of improvement in symptoms.

It’s important for individuals receiving Berinert to follow their healthcare provider’s instructions carefully and to report any unusual symptoms or reactions during or after the infusion. Berinert is typically used as an on-demand treatment for acute HAE attacks or as pre-procedure prophylaxis, so the timing and frequency of administration will depend on the individual’s specific situation and medical needs.

Other uses for this medicine

While Berinert is primarily used for the treatment of hereditary angioedema (HAE), it may also be used in certain other clinical situations, including:

• Acquired Angioedema (AAE): In some cases of acquired angioedema, where there is a deficiency in C1 esterase inhibitor due to other medical conditions, Berinert may be used.
• Prophylaxis Before Surgery or Medical Procedures: Berinert can be administered before surgical or medical procedures in individuals with HAE to prevent angioedema attacks triggered by the procedure.
• Treatment of Acute Laryngeal Attacks: Berinert may be used in the treatment of acute laryngeal attacks in individuals with HAE, where swelling occurs in the throat, potentially leading to airway obstruction.

What special precautions should I follow?

Special precautions should be followed when using Berinert:

• Allergic Reactions: Individuals with a known hypersensitivity to C1 esterase inhibitor products should not use Berinert. It’s essential to inform your healthcare provider of any allergies before starting treatment.
• Thrombotic Events: There have been reports of thrombotic events (blood clots) in patients receiving C1 esterase inhibitor products, including Berinert. Individuals with a history of thrombotic events or underlying risk factors for thrombosis should be monitored closely during treatment.
• Pregnancy and Breastfeeding: The safety of Berinert during pregnancy and breastfeeding has not been established. It should only be used if the potential benefits outweigh the risks and under the guidance of a healthcare provider.
• Transmission of Infectious Agents: Berinert is made from human plasma and may carry a risk of transmitting infectious agents, such as viruses and variant Creutzfeldt-Jakob disease (vCJD). However, steps are taken during the manufacturing process to minimize this risk.
• Drug Interactions: Berinert may interact with other medications. It’s important to inform your healthcare provider about all medications, vitamins, and supplements you are taking before starting Berinert treatment.

Always follow your healthcare provider’s instructions and recommendations when using Berinert, and report any unusual symptoms or side effects promptly.

What special dietary instructions should I follow?

Regarding special dietary instructions, there are no specific dietary restrictions associated with Berinert. However, maintaining a healthy and balanced diet can contribute to overall well-being and may help manage symptoms associated with hereditary angioedema (HAE). Ensure you stay hydrated and avoid excessive consumption of alcohol, as dehydration and alcohol consumption may exacerbate HAE symptoms.

What should I do if I forget a dose?

If you forget a dose of Berinert, contact your healthcare provider or treatment center for guidance. It’s essential to follow your prescribed treatment schedule to effectively manage hereditary angioedema (HAE) symptoms. Do not attempt to double the dose to make up for the missed one unless advised by your healthcare provider.

What side effects can this medication cause?

Berinert, like any medication, can cause side effects, although not everyone experiences them. Common side effects of Berinert may include:

• Headache: Some individuals may experience headaches after receiving Berinert infusion.
• Nausea: Nausea is another common side effect reported by some individuals.
• Dizziness: Feeling dizzy or lightheaded may occur during or after Berinert infusion.
• Injection Site Reactions: Redness, swelling, or discomfort at the injection site are possible side effects.
• Fever: Some individuals may develop a low-grade fever after receiving Berinert.
• Rash or Itching: Skin reactions such as rash or itching may occur in some individuals.
• Flu-like Symptoms: Symptoms resembling those of the flu, such as fatigue and muscle aches, can sometimes occur.
• Nasopharyngitis: Inflammation of the nose and throat may occur as a side effect.

Serious side effects of Berinert are rare but can include:

• Allergic Reactions: Severe allergic reactions to Berinert, though uncommon, can occur. Symptoms may include difficulty breathing, chest tightness, swelling of the face or throat, and hives. Seek immediate medical attention if you experience any signs of a severe allergic reaction.
• Thrombotic Events: There is a risk of blood clots (thrombotic events) associated with Berinert use. Symptoms may include pain, swelling, warmth, redness, or numbness in the extremities. Contact your healthcare provider immediately if you experience any of these symptoms.
• Hypersensitivity Reactions: Some individuals may experience hypersensitivity reactions, which may include symptoms such as rash, itching, or hives.

It’s essential to report any side effects or adverse reactions to your healthcare provider promptly. They can provide guidance on managing side effects and determine whether any further action is needed.

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

When it comes to the storage and disposal of Berinert, here’s what you should know:

Storage:

• Berinert should be stored in the refrigerator at a temperature between 2°C to 8°C (36°F to 46°F). Do not freeze.
• Keep Berinert in its original carton to protect it from light.
• Do not use Berinert beyond the expiration date printed on the packaging.
• If necessary, Berinert can be stored at room temperature (up to 25°C or 77°F) for a single period of up to 6 months. Once stored at room temperature, Berinert should not be returned to the refrigerator.

Disposal:

• Dispose of unused or expired Berinert in accordance with local regulations for hazardous waste disposal.
• Do not dispose of Berinert in household trash or down the drain unless instructed to do so by your healthcare provider or pharmacist.

In case of emergency/overdose

In the event of an emergency or overdose of Berinert, seek immediate medical attention or contact a poison control center. Symptoms of an overdose may include excessive bleeding or clotting, allergic reactions, or other severe adverse reactions.

What other information should I know?

• Before using Berinert, inform your healthcare provider if you have any allergies, medical conditions, or are taking any other medications.
• Keep a record of each Berinert infusion, including the date, time, dose administered, and any side effects experienced.
• Berinert is made from human plasma and may carry a risk of transmitting infectious agents, despite rigorous screening and purification processes. However, the risk is considered low.
• Inform all healthcare professionals involved in your care, including dentists and surgeons, that you are receiving Berinert.
• Attend all scheduled appointments with your healthcare provider for monitoring and follow-up assessments.

Following these guidelines for storage, disposal, and handling of Berinert can help ensure its effectiveness and minimize any potential risks associated with its use. Always consult your healthcare provider or pharmacist if you have any questions or concerns about Berinert or its administration.