Spartina


(Tirzepatide)


What is it?

What is Spartina®?

Spartina® is a medicine that contains an active substance called tirzepatide. Each pre-filled syringe in Physioject (auto-injector device) contains one of the following doses: 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg or 15 mg in 0.5 ml solution.

How does Spartina® work?

Spartina® is used to treat adults with type 2 diabetes mellitus by reducing the level of sugar in the body only when the levels of sugar are high. Spartina® is also used for weight loss and weight maintenance in adults. Spartina® primarily works by regulating your appetite, giving you a sense of satiety (‘fullness’), making you feel less hungry and experience less food cravings. This will help you eat less food and reduce your body weight. Spartina® is also used for treatment of moderate to severe obstructive sleep apnea in people with obesity.

Indications

What is Spartina® used for?

  • In type 2 diabetes in adults, Spartina® is used on its own (when you can’t take metformin) or with other diabetes medicines (taken orally and/or insulin by injection).
  • Spartina® is also used together with reduced-calorie diet and increased physical activity for weight loss and to help keep the weight under control in adults who have:
  • a BMI of 30 kg/m² or greater (obesity) or
  • a BMI of at least 27 kg/m² but less than 30 kg/m² (overweight) and weight-related health problems (such as prediabetes, type 2 diabetes, high blood pressure, abnormal levels of fats in the blood, breathing problems during sleep called ‘obstructive sleep apnea’ or a history of heart attack, stroke or blood vessel problems).
  • Spartina® is also used together with reduced-calorie diet and increased physical activity for the treatment of moderate to severe obstructive sleep apnea in people with obesity.

Contraindications

Contraindications

Who should not use Spartina®?

Do not use Spartina® if:

  • You are allergic to tirzepatide or any of the other ingredients of this medicine.
  • You have a personal or family history of medullary thyroid carcinoma.
  • You have multiple endocrine neoplasia syndrome type 2 (MEN 2).

Important information

What should you know about taking Spartina®?

Talk to your doctor or pharmacist before using Spartina® if:

  • You have severe problems with food digestion or food remaining in your stomach for longer than normal (including severe gastroparesis).
  • You have ever had pancreatitis (inflammation of the pancreas that may cause severe pain in the stomach and back that does not go away).
  • You have a problem with your eyes (diabetic retinopathy or macular edema).
  • You are using a sulfonylurea (such as glibenclamide or gliclazide) or insulin for your diabetes, as low blood sugar can occur. Your doctor may need to change your dose of these other medicines to reduce this risk.

When starting treatment with Spartina®, in some cases you may experience loss of fluids/dehydration, due to nausea, vomiting and/or diarrhea, which may lead to a decrease in kidney function. It is important to avoid dehydration by drinking plenty of fluids.

Children and Adolescents:

This medicine should not be given to children and adolescents under 18 years of age because it has not been studied in this age group.

Pregnancy and breast-feeding:

This medicine should not be used during pregnancy as the effects on an unborn child are not known. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. It is recommended to use contraception while using this medicine. If you are using oral contraceptives, it is recommended to switch to non-oral contraceptive methods or add a barrier method (e.g., a condom) for 4 weeks after starting Spartina® treatment and for 4 weeks after each dose increase beside using oral contraceptives.

It is unknown whether tirzepatide passes into breast milk. If you are breast-feeding or are planning to breast-feed, talk to your doctor before using this medicine. The decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.

Driving and Using Machines:

It is unlikely that Spartina® will affect your ability to drive and use machines. However, if you use Spartina® in combination with a sulfonylurea or insulin, low blood sugar may occur which may reduce your ability to concentrate. Avoid driving or using machines if you get any signs of low blood sugar like headache, drowsiness, weakness, dizziness, feeling hungry, confusion, irritability, fast heartbeat and sweating.

If you use more Spartina® than you should:

If you use more Spartina® than you should talk to your doctor immediately. Too much of this medicine may cause low blood sugar and can make you feel sick or be sick.

If you forget to use Spartina®:

If you forget to inject a dose and,

  • It has been 4 days or less since you should have used Spartina®, use it as soon as you remember. Then inject your next dose as usual on your scheduled day.
  • If it has been more than 4 days since you should have used Spartina®, skip the missed dose. Then inject your next dose as usual on your scheduled day.

Do not use a double dose to make up for a forgotten dose.

The minimum time between two doses must be at least 3 days.

If you stop using Spartina®:

Do not stop using Spartina® without talking with your doctor. If you stop using Spartina®, and you have type 2 diabetes, your blood sugar levels can increase.

What other drugs could affect Spartina®?

Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines.

How to use Spartina®?

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure how to use this medicine.

Spartina® should be injected subcutaneously on the same day each week in the abdomen (5 cm away from the belly button), In the front of the thighs (about 5 cm above the knee and 5 cm below the groin) and back and side of the upper arms halfway between the elbow and shoulder.

You can use the same area of your body each week but be sure to choose a different injection site within that area. If you also inject insulin choose a different injection site for that injection.

Side Effects

What are the possible side effects of Spartina®?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

  • Gastrointestinal side effects: nausea, diarrhea, vomiting and constipation. These side effects are most common when first starting Spartina® but decrease over time in most patients. Solutions such as gradual dose titration, drinking adequate water, eating smaller meals, eating easily digestible foods instead of fatty and spicy foods and limiting alcohol consumption may be helpful for prevention and management of possible gastrointestinal side effects.
  • Low blood sugar may occur when Spartina® is used for the treatment of type 2 diabetes with medicines that contain a sulfonylurea and/or insulin. Symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, feeling hungry, confusion, irritability, fast heartbeat and sweating.

Storage

How to store Spartina®?

  • Spartina® should be used in the refrigerator (2 to 8 °C). Do not freeze. If the Physioject has been frozen, do not use it.
  • Protect the Physioject from direct sunlight.
  • Do not use this medicine if you notice that the Physioject is damaged, or the medicine is cloudy, discolored or has particles in it.
  • Do not use this medicine after the expiry date which is stated on the Physioject label and on the carton after EXP.

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

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