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Overview: Givlaari is used to treat people with a rare, genetic condition called acute hepatic porphyria. This medicine works by lowering harmful substances that can cause porphyria attacks. Givlaari is given as an injection under your skin by your health care provider. Pain, itching, swelling, or redness near the injection site is a common side effect. Tell your health care provider right away if you have severe pain in the upper part of your belly that travels to your back.

Uses

What is Givlaari used for?

Givlaari (givosiran) is commonly used for acute hepatic porphyria.

Givlaari may also be used for other conditions as determined by your health care provider.

How does Givlaari work (mechanism of action)?

People with acute hepatic porphyria (AHP) have a genetic change or mutation. The change affects a protein (enzyme) that controls the process to make a substance called heme. In people with AHP, the process to make heme does not work normally, and high levels of certain harmful substances can build up in the body. Givlaari lowers the amount of the enzyme that controls this process, which helps lower the buildup of these harmful substances. This may help lower the number of porphyria attacks.

How is Givlaari supplied (dosage forms)?

Givlaari is available in an injectable form that is given by a health care provider.

How should I store Givlaari?

Givlaari is usually given by a health care provider in a hospital or clinic. You will not store it at home.

Side Effects

What are the most common side effects of Givlaari?

The most common side effects of Givlaari are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Nausea
  • Pain, itching, swelling, discoloration, or redness near the injection site

There may be other side effects of Givlaari that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Givlaari?

While less common, the most serious side effects of Givlaari are described below, along with what to do if they happen.

Severe Allergic Reactions. Givlaari may cause allergic reactions, which can be serious. Get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching or skin rash
  • Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Inflammation of the Pancreas (Pancreatitis). Givlaari may cause inflammation of the pancreas, which is called pancreatitis. Call your health care provider right away if you have symptoms of pancreatitis, including vomiting or severe pain in the upper part of your belly that travels to your back.

Liver Damage. Liver damage, also called hepatotoxicity, can happen when using Givlaari. Keep all appointments to have your blood checked. Call your health care provider right away if you have any of the following symptoms of liver damage.

  • Nausea or vomiting
  • Stomach or belly pain
  • Fever
  • Weakness or unusual tiredness
  • Itching
  • Loss of appetite
  • Light-colored poop
  • Dark-colored urine (pee)
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Kidney Problems. Changes in kidney function can happen when using Givlaari. Your health care provider may want to check how well your kidneys are working. Keep all appointments to have your blood or pee (urine) checked.

Warnings & Precautions

Who should not use Givlaari?

Allergies to Ingredients. People who are allergic to any of the following should not use Givlaari.

  • Givlaari
  • Givosiran
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Givlaari.

What should I know about Givlaari before using it?

Givlaari is usually given by a health care provider in a hospital or clinic.

Keep all appointments, including for blood tests, with your health care provider. This will help them know if it is safe for you to keep using this medicine.

Givlaari can increase the level of a substance called homocysteine in your blood. High homocysteine levels may cause problems. Take any vitamins that your health care provider recommends, such as vitamin B6 or a multivitamin.

What should I tell my health care provider before using Givlaari?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Givlaari is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

Other Medicines and Supplements. Givlaari may interact with other medicines and supplements. Before using Givlaari, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. It is not known if or how Givlaari could affect pregnancy or harm a fetus. Tell your health care provider if you are pregnant or plan to become pregnant. Your health care provider will let you know if you should use Givlaari while you are pregnant or trying to get pregnant.

Breastfeeding. It is not known if Givlaari passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should use Givlaari while breastfeeding.

How can I get more information about Givlaari?

For more information about Givlaari, you can visit the drugmaker’s website at www.givlaari.com or call them at 833-256-2748.

Interactions

Does Givlaari interact with foods or drinks?

You may want to avoid or limit foods or drinks with caffeine. Givlaari may increase the amount of caffeine in your body. Too much caffeine can make you feel anxious and cause health problems.

It is unknown if drinking alcohol will affect Givlaari. The risk of attacks of acute hepatic porphyria may increase if you drink alcohol while using Givlaari. Talk to your health care provider about staying away from things like alcohol that can trigger an attack.

Does Givlaari interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are taking any product that contains caffeine, which is often found in medicines for reducing water weight (diuretics), staying awake, headaches, and hangover relief.

Givlaari may alter the blood levels of some other medicines. Tell your health care provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Givlaari. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Givlaari?

If you or someone else has used too much Givlaari, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Givlaari?

Givlaari is usually given by a health care provider in a hospital or clinic. If you miss an appointment to get your Givlaari dose, call to make another appointment as soon as possible.