Maciza®

Description

What is Maciza^®?

Each Maciza^® pen contains 18 mg/3 ml liraglutide. Liraglutide is an analog of human Glucagon-Like Peptide-1 (GLP-1) and acts as a GLP-1 receptor agonist. Maciza^® injection pen can be obtained with a physician's prescription.

How does Maciza^® work?

Maciza^® is similar to a natural occurring hormone called Glucagon-Like Peptide-1 (GLP-1) that is released from the intestine after a meal. Maciza^® works by acting on receptors in the brain that control your appetite, causing you to feel fuller and less hungry. This may help you eat less food and reduce your body weight.

Indications

Maciza^® (liraglutide) multiple dose pen injection is indicated as:

• In adults (aged 18 and above), Maciza^® is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in patients with an initial Body Mass Index (BMI) of:

• ≥30 kg/m² (obesity), or
• ≥27 kg/m² to <30 kg/m² (overweight) in the presence of at least one weight-related comorbidity such as prediabetes, type 2 diabetes mellitus, hypertension or dyslipidaemia.

• In adolescents (≥12 years), Maciza^® can be used as an adjunct to healthy nutrition and increased physical activity for weight management in patients with:

• Obesity (BMI corresponding to ≥30 kg/m² for adults by international cut-off points) and
• Body weight above 60 kg.

Contraindications

People with the following conditions should avoid using Maciza^®:

• Hypersensitivity to liraglutide or any component of the formulation
• Personal or family history of medullary thyroid cancer (MTC)
• Patients with multiple endocrine neoplasia syndrome type 2 (MEN II)

• Pregnancy

Important information

• Maciza^® is for subcutaneous use only. It must not be administered intravenously or intramuscularly.
• Maciza^® is administered once daily at any time, regardless of meals. It should be injected in the abdomen, thigh or upper arm.
• Use a new needle for each injection.

• Do not share your Maciza^® pen with others, even if you have changed its needle. Sharing pens increases the risk of infection. After each injection, remove the needle from the pen, discard it carefully and store the Maciza^® pen without the needle.

• If you are using Maciza^® concomitantly with insulin, administer as separate injections (do not mix in the same syringe).
• Do not use this medicine if the solution is not clear and colorless.
• Maciza^® and Melitide^® contain the same active ingredient (liraglutide) and should not be used together or with other GLP-1 receptor agonists.

In what cases should you consult your doctor before using Maciza^®?

• You have a history of pancreatic, kidney or liver diseases.

• You have any other medical conditions or severe stomach problems including slow gastric emptying (gastroparesis) or problems with digestion.

• If you are pregnant, breastfeeding or intending to become pregnant.

• You had suicidal thoughts or a history of suicide.

• Before using Maciza^®, inform your doctor about all your medications, including prescription or non-prescription medications or anti-diabetics such as insulin or sulfonylurea (for example glibenclamide).

Side Effects

• What are the side effects of Maciza^®?

  Like all medicines, Maciza^® can cause side effects in some patients.

  The most common side effects of Maciza^® include nausea, diarrhea, vomiting, loss of appetite, indigestion and constipation. These symptoms are temporary and most patients will develop tolerance to these symptoms.

  If you experience any of the following side effects, stop using Maciza^® and consult your doctor:

  - Swelling in the neck area, hoarseness, difficulty swallowing or breathing

  - Severe persistent pain with/without nausea in the abdomen

  - Allergic reactions including swelling of the face, lips, tongue or throat, breathing problems or difficulty swallowing, rash or itching.

  If you experience any adverse effects that might be caused by taking the medicine, inform your pharmacist or physician.

  For more information, please refer to the product`s leaflet.

Storage

• Store in a refrigerator (2-8°C). Once you start using the pen, keep the pen for 30 days when stored at a temperature below 30˚C or in a refrigerator (2-8°C), away from the freezer compartment.
• Prevent the pen containing the medicine from freezing and do not use it if Maciza^® is frozen.
• It is recommended to keep Maciza^® in its original packaging and protect it from direct contact with sunlight or heat.