Giapreza

What is Giapreza used for?

Giapreza is a prescription medicine that is used to treat low blood pressure.

Description

Angiotensin II is a naturally occurring peptide hormone of the renin-angiotensin-aldosterone system (RAAS) that causes vasoconstriction and an increase in blood pressure. GIAPREZA is a sterile, aqueous solution of synthetic human angiotensin II for intravenous administration by infusion. Each 1 mL of GIAPREZA contains 2.5 mg angiotensin II equivalent to an average of 2.9 mg angiotensin II acetate, 25 mg mannitol, and Water for Injection adjusted with sodium hydroxide and/or hydrochloric acid to pH of 5.5.

The chemical name of the synthetic angiotensin II acetate is L-Aspartyl-L-arginyl-L-valyl-Ltyrosyl-L-isoleucyl-L-histidyl-L-prolyl-L-phenylalanine, acetate salt. The counter ion acetate is present in a non-stoichiometric ratio. It is a white to off-white powder, soluble in water.

The structure of angiotensin II acetate is shown below.

Molecular formula: C 50H 71N 13O 12 ∙ (C 2H 4O 2) n; (n= number of acetate molecules; theoretical n = 3)

Average molecular weight: 1046.2 (as free base).

Mechanism of Action

Angiotensin II raises blood pressure by vasoconstriction and increased aldosterone release. Direct action of angiotensin II on the vessel wall is mediated by binding to the G-protein-coupled angiotensin II receptor type 1 on vascular smooth muscle cells, which stimulates Ca 2+/calmodulin-dependent phosphorylation of myosin and causes smooth muscle contraction.

Before taking Giapreza, tell your doctor:

• If you are allergic to Giapreza; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Giapreza with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Giapreza?

• Tell all of your health care providers that you take Giapreza. This includes your doctors, nurses, pharmacists, and dentists.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Giapreza while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is Giapreza best taken?

Use Giapreza as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as an infusion into a vein over a period of time.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are the side effects of Giapreza that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of too much acid in the blood (acidosis) like confusion; fast breathing; fast heartbeat; a heartbeat that does not feel normal; very bad stomach pain, upset stomach, or throwing up; feeling very sleepy; shortness of breath; or feeling very tired or weak.
• Any unexplained bruising or bleeding.
• A fast heartbeat.
• Mood changes.
• The chance of blood clots may be raised in some people. Blood clots may be in the arms, legs, or lungs; heart attack; or stroke. You may need a blood thinner to prevent blood clots. Follow what your doctor has told you. Call your doctor right away if you have chest pain or pressure; coughing up blood; shortness of breath; or pain, warmth, or swelling of the legs or arms. Call your doctor right away if you have signs of heart attack like chest pain that may spread to the arms, neck, jaw, back, or stomach; abnormal sweating; feeling sick; or throwing up. Call your doctor right away if you have signs of stroke like weakness on 1 side of the body; eyesight, speech, or balance problems; confusion; drooping on one side of the face; or severe headache.

What are some other side effects of Giapreza?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Giapreza?

• If you need to store Giapreza at home, talk with your doctor, nurse, or pharmacist about how to store it.

Label

PACKAGE LABEL – 1 ML SINGLE-DOSE VIAL LABEL

PACKAGE LABEL – 1 ML SINGLE VIAL CARTON LABEL