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Tilpazan Pfs Inj

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1PFSProduct code 279800

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Product information

Manufacturer
Lupin Ltd-pinnacle Div
Category
Other
Composition
Not provided
Packaging
1PFS
Box / case pack
1 / —
Description

TILPAZAN PFS INJ

Name: Tilpazan (brand name) is a pre-filled solution for injection, with the generic name Inclisiran.

Composition: The active ingredient in Tilpazan PFS INJ is Inclisiran, typically 284 mg. It is a small interfering RNA (siRNA) therapy.

Uses: Tilpazan is prescribed to lower low-density lipoprotein cholesterol (LDL-C), often referred to as "bad" cholesterol. It is used as a complement to statin medication and diet for adults with primary hypercholesterolemia (including heterozygous familial hypercholesterolemia) and atherosclerotic cardiovascular disease (ASCVD) who require further LDL-C reduction. Lowering LDL-C helps reduce the risk of cardiovascular events like heart attack and stroke.

Dosage and Administration: Tilpazan PFS INJ is administered as a subcutaneous injection, usually into the abdomen, upper arm, or thigh, by a healthcare professional. The typical dosing schedule involves an initial injection, a second injection at 3 months, and subsequent doses every 6 months.

Side Effects: Common side effects may include injection site reactions (redness, rash, pain), arthralgia (joint pain), bronchitis, fever, chills, headache, dizziness, cough, diarrhea, back pain, pain in extremities, and urinary tract infection. Most common side effects are usually mild and may not require medical treatment.

Precautions: Tilpazan should not be used if there is an allergy to Inclisiran or its components. It is not recommended during pregnancy or breastfeeding without consulting a doctor, and it is not for children and adolescents under 18. Patients should continue statin therapy and a cholesterol-lowering diet while on Tilpazan. Inform your doctor about any kidney or liver disorders, breathing or heart problems, or intolerance to sugars, and all other medications being taken.

Storage: Tilpazan PFS INJ should be stored at room temperature, between 20°C to 25°C (68°F to 77°F), or below 30°C. It must be protected from light and kept in its original packaging. Keep it out of reach of children and pets.

Frequently asked questions

Here are the frequently asked questions about TILPAZAN PFS INJ, also known by its active ingredient, Inclisiran:

What is TILPAZAN PFS INJ used for?

TILPAZAN PFS INJ is used to help lower high cholesterol levels, specifically low-density lipoprotein cholesterol (LDL-C), often referred to as "bad" cholesterol. It is prescribed for adults with heterozygous familial hypercholesterolemia (HeFH) or atherosclerotic cardiovascular disease (ASCVD) who require further LDL-C reduction despite lifestyle changes and maximally tolerated statin therapy. It is part of a comprehensive treatment plan that includes a healthy diet and exercise.

How does TILPAZAN PFS INJ work?

TILPAZAN PFS INJ contains Inclisiran, a small interfering RNA (siRNA) therapeutic. It works by targeting the liver to reduce the production of a protein called PCSK9 (proprotein convertase subtilisin/kexin type 9). By inhibiting PCSK9 synthesis, the number of LDL receptors on liver cells increases, which in turn enhances the liver's ability to clear LDL-C from the bloodstream, thereby lowering cholesterol levels.

What is the usual dosage of TILPAZAN PFS INJ?

TILPAZAN PFS INJ is given as a 284 mg subcutaneous injection (under the skin) by a healthcare professional. The dosing schedule typically involves an initial dose, a second dose at 3 months, and then maintenance injections every 6 months thereafter. It is not intended for self-administration.

What are the possible side effects of TILPAZAN PFS INJ?

Common side effects include injection site reactions (such as pain, swelling, redness, or rash), joint pain (arthralgia), bronchitis, urinary tract infection, diarrhea, pain in extremities, shortness of breath, headache, dizziness, and flu-like symptoms. Less common but more serious side effects can include rare allergic reactions and transient elevations in liver enzymes.

Is TILPAZAN PFS INJ safe during pregnancy or breastfeeding?

TILPAZAN PFS INJ is generally not recommended during pregnancy or breastfeeding due to limited safety data in humans. Animal studies have shown potential harmful effects on the developing baby. If you are pregnant, planning to become pregnant, or breastfeeding, you should consult your doctor to discuss the potential benefits and risks.

Can TILPAZAN PFS INJ be taken with other medications?

Yes, TILPAZAN PFS INJ is designed to be used in combination with other lipid-lowering therapies, particularly maximally tolerated statin therapy. It has a low potential for typical drug-drug interactions due to its specific mechanism of action. However, it is important to inform your healthcare provider about all the medications, supplements, and herbal products you are currently taking.

What precautions should be taken with TILPAZAN PFS INJ?

You should not take TILPAZAN PFS INJ if you are allergic to Inclisiran or any of its components. Inform your doctor if you have any liver or kidney conditions, as caution is advised with liver disease. Regular monitoring of cholesterol levels is essential. Avoid injecting in areas with active skin disease or injury. TILPAZAN PFS INJ is not recommended for children under 18 years of age.

What happens if a dose of TILPAZAN PFS INJ is missed?

If a dose is missed by less than 3 months, it should be administered as soon as possible, and the regular dosing schedule should be continued. If more than 3 months have passed since the missed dose, your doctor will likely restart your treatment schedule.

How should TILPAZAN PFS INJ be stored?

TILPAZAN PFS INJ should be stored in a cool and dry place, away from direct sunlight, typically between 20°C to 25°C (68°F to 77°F) or below 30°C. It should be kept in its original packaging and protected from light. Keep it out of the reach of children and pets. If the pre-filled syringe has been refrigerated (check specific product instructions if it was), allow it to reach room temperature for about 30 minutes before use. Do not shake the syringe.