Givlaari
Givlaari is used for the treatment of adults with acute hepatic porphyria (AHP), a genetic disorder resulting in the buildup of toxic porphyrin molecules.
Givlaari Overview
Givlaari is a prescription medication used for the treatment of adult patients with acute hepatic porphyria (AHP). Porphyria attacks can lead to severe pain and paralysis, respiratory failure, seizures and mental status changes.
Givlaari belongs to a new class of drugs called siRNAs, a class of therapeutics that can target hereditary diseases by affecting gene function. Givlaari works by reducing the amount of ALAS1 in the liver, which leads to a reduction in levels of the neurotoxins ALA and PBG. ALA and PBG are associated with attacks and other AHP symptoms.
Givlaari comes in an injectable form to be given into the abdomen, the back or side of the upper arms, or the thighs. Givlaari is given once a month as a subcutaneous injection (under the skin) by a healthcare professional.
Common side effects for patients include nausea and injection site reactions.
How was your experience with ?
Givlaari Cautionary Labels
Uses of Givlaari
Givlaari is a prescription medication used to treat acute hepatic porphyria (AHP) in adults. There are 4 types of AHP: acute intermittent porphyria (AIP), variegate porphyria (VP), hereditary coproporphyria (HCP), and ALA-dehydratase deficient porphyria (ADP).
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
Generic
Givosiran
For more information on this medication choose from the list of selections below.
Side Effects of Givlaari
Serious side effects have been reported with Givlaari. See the "Givlaari Precautions" section.
Common side effects of Givlaari include nausea and injection site reactions.
This is not a complete list of Givlaari side effects. Ask your doctor or pharmacist for more information.
Tell your doctor if you have any side effect that bothers you or does not go away.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Givlaari Interactions
Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins and herbal supplements. Especially tell your doctor if you take:
- Alosetron (Lotronex)
- Caffeine
- Clozapine (Clozaril)
- Flutamide (Eulexin)
- Frovatriptan (Frova)
- Melatonin
- Mexiletine (Mexitil)
- Mirtazapine (Remeron)
- Olanzapine (Zyprexa)
- Ramelteon (Rozerem)
- Rasagiline (Azilect)
- Ropinirole (Requip)
- Tacrine (Cognex)
- Theophylline
- Tizanidine (Zanaflex)
- Triamterene (Dyrenium)
- Zolmitriptan (Zomig)
- atomoxetine (Strattera)
- desipramine (Norpramin)
- dextromethorphan
- eliglustat (Cerdelga)
- nebivolol (Bystolic)
- nortriptyline (Pamelor)
- perphenazine (Trilafon)
- tolterodine (Detrol and Detrol LA)
- venlafaxine (Effexor XR)
This is not a complete list of Givlaari drug interactions. Ask your doctor or pharmacist for more information.
Givlaari Precautions
Givlaari can cause:
-
Severe allergic reaction. Tell your doctor or nurse right away if you experience any of the following signs or symptoms of a severe allergic reaction during treatment:
- Swelling – mainly of the lips, tongue or throat which makes it difficult to swallow or breathe
- Breathing problems or wheezing
- Feeling dizzy or fainting
- Rash or hives
- Itching
If you have a severe allergic reaction, your doctor or nurse will stop Givlaari treatment right away and you may need to take other medicines to control the symptoms.
-
Liver problems. Your doctor will check your liver function by doing blood tests:
- Before you start using Givlaari
- Once a month for the first 6 months of treatment
- And when they think it is needed
If these tests show abnormal results, your doctor or nurse will decide whether to temporarily interrupt or stop treatment with Givlaari.
-
Kidney problems. Your doctor will check how your kidneys are working while you are using Givlaari.
-
Injection site reactions. Givlaari is given as an injection under the skin (called a "subcutaneous injection"). Reactions to this injection may happen during treatment with Givlaari.
Tell your doctor or nurse right away if you experience any of the following symptoms of an injection site reaction during treatment: redness, pain, itchiness, rash, discoloration, or swelling around the injection site.
Do not use Givlaari if you have ever had a severe allergic reaction to Givlaari.
Givlaari Food Interactions
Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Givlaari are no specific foods that you must exclude from your diet when receiving this medication.
Inform MD
Before taking Givlaari, tell your doctor about all of your medical conditions. Especially tell your doctor if you:
- have kidney or liver problems
- are pregnant or plan to become pregnant
- are breastfeeding or plan to breastfeed
Do not use Givlaari if you have ever had a severe allergic reaction to Givlaari.
Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.
Givlaari and Pregnancy
Tell your doctor if you are pregnant or plan to become pregnant.
There are no well-done studies that have been done in humans with Givlaari. In animal studies, pregnant animals were given this Givlaari and both the pregnant animal and the babies showed medical issues related to this medication. Therefore, this medication may only be used if the potential benefits to the mother outweigh the potential risks to the unborn child.
Givlaari and Lactation
Tell your doctor if you are breastfeeding or plan to breastfeed.
It is not known if Givlaari crosses into human milk. Because many medications can cross into human milk and because the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Givlaari.
Givlaari Usage
Givlaari is given once a month as a subcutaneous injection (under the skin) by a healthcare professional. If a dose is missed, they should administer Givlaari as soon as possible. Your doctor may adjust your dose if you experience side effects.
Your doctor will check your liver function before and during treatment with Givlaari by doing blood tests. If these tests show abnormal results, your doctor or nurse will decide whether to temporarily interrupt or stop treatment with Givlaari.
Your doctor will also check your kidney function while you are using Givlaari.
Givlaari Dosage
The recommended dose of Givlaari is 2.5 mg/kg administered via subcutaneous injection once monthly. Dosing is based on actual body weight.
Givlaari Overdose
Givlaari is usually administered by a healthcare provider in a medical setting making it unlikely for an overdose to occur. However, if overdose is suspected, seek emergency medical attention.