Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Amvuttra 25 mg solution for injection in pre-filled syringe
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Vutrisiran sodium may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
The active substance in Amvuttra is vutrisiran. What Amvuttra is used for Amvuttra is used for the treatment of an illness called 'ATTR amyloidosis'. This illness can run in families and may also be caused by aging. ATTR amyloidosis is caused by problems with a protein in the body called 'transthyretin' (TTR). This protein is made mostly in the liver and carries vitamin A and other substances around the body. In people with this illness, small fibres of TTR protein clump together to make deposits called 'amyloid'. Amyloid can build up around or within the nerves, heart, and other places in the body, stopping them from working normally. This causes the symptoms of the illness. How Amvuttra works Amvuttra works by lowering the amount of TTR protein made by the liver which means there is less TTR protein in the blood that can form amyloid. This can help to reduce the effects of this illness. Amvuttra is used in adults only.
2.
What you need to know before you take it
e Amvuttra
Do not use Amvuttra • If you have ever had a severe allergic reaction to vutrisiran, or any of the other ingredients of this medicine (listed in section 6). If you are not sure, talk to your doctor, pharmacist or nurse before you use this medicine.
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Warnings and precautions Lowered vitamin A levels in the blood and vitamin supplements Amvuttra lowers the amount of vitamin A in your blood. Your doctor will ask you to take a daily vitamin A supplement. Please follow the vitamin A dose recommended by your doctor. Signs of low vitamin A may include: sight problems especially at night, dry eyes, hazy, or cloudy vision.
- If you notice a change in your vision or any other eye problems whilst using Amvuttra, talk to your doctor. Your doctor may send you to an eye specialist for a check-up. Both too high and too low levels of vitamin A can harm the development of your unborn child. Therefore, women of childbearing age should exclude any pregnancy before starting treatment with Amvuttra and practise effective contraception (see section "Pregnancy, breast-feeding and contraception" below). • Vitamin A levels may remain low for more than 12 months after the last dose of Amvuttra. • Tell your doctor if you are planning to become pregnant. Your doctor will tell you to stop taking Amvuttra and vitamin A supplementation. Your doctor will also ensure that your vitamin A levels have returned to normal before conception is attempted. • Tell your doctor if you have an unplanned pregnancy. Your doctor will tell you to stop taking Amvuttra. In the first 3 months of your pregnancy, your doctor may tell you to stop taking vitamin A supplementation. During the last 6 months of your pregnancy, you doctor may tell you to resume the vitamin A supplementation if your vitamin A levels have not yet returned to normal, because of the increased risk of vitamin A deficiency during the last 3 months of your pregnancy. Children and adolescents Amvuttra is not recommended in children and adolescents under 18 years of age. Other medicines and Amvuttra Tell your doctor, pharmacist, or nurse if you are using, have recently used or might use any other medicines. Pregnancy, breast-feeding and contraception If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before starting this medicine. Pregnancy You should not use Amvuttra if you are pregnant. Women of childbearing age Amvuttra will reduce the level of vitamin A in your blood and vitamin A is important for normal development of your unborn child (see "Warnings and precautions" above). • You should use effective contraception during treatment with Amvuttra – if you are a woman who is able to become pregnant. • Talk to your doctor or nurse about suitable methods of contraception. • Pregnancy should be excluded before starting treatment with Amvuttra. • Tell your doctor if you are planning to become pregnant or if you have an unplanned pregnancy. Your doctor will tell you to stop taking Amvuttra. Breast-feeding It is not known if vutrisiran passes into breast milk. Your doctor will consider the potential benefits of treatment for you – compared with the risks of breast-feeding for your baby. 3
Driving and using machines Amvuttra is unlikely to affect your ability to drive or use machines. Your doctor will tell you whether your condition allows you to drive vehicles and use machines safely. Amvuttra contains sodium This medicine contains less than 1 mmol sodium (23 mg) per mL, that is to say essentially 'sodiumfree'.
3.
How to take it
Amvuttra
Amvuttra may be self-administered or administered by a caregiver or a healthcare professional. Your doctor or healthcare provider will show you and/or your caregiver how to prepare and inject a dose of Amvuttra before you do it yourself. For instructions on how to use Amvuttra, please read "Instructions for use" at the end of this leaflet. How much Amvuttra you should use The recommended dose is 25 mg once every 3 months. Where the injection is administered Amvuttra is administered by injection under the skin ('subcutaneous injection') into your stomach area (abdomen), upper arm (if someone else is giving the injection) or thigh. How long to use Amvuttra Your doctor will tell you how long you need to use Amvuttra. Do not stop treatment with Amvuttra unless your doctor tells you to. If you use more Amvuttra than you should In the unlikely event that you use too much (an overdose), contact your doctor or pharmacist, even if you have no symptoms. Your doctor will check you for side effects. If you forget to use Amvuttra If a dose is missed, administer Amvuttra as soon as possible. Thereafter, resume dosing every 3 months, from the most recently administered dose. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor, pharmacist, or nurse if you notice any of the following side effects: Common: may affect up to 1 in 10 people • Redness, pain, itching, bruising, or warmth where the injection was administered • Blood tests showing increases in a liver enzyme called alkaline phosphatase and alanine transaminase Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system:
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United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store By reporting side effects you can help provide more information on the safety of this medicine.
5.
How to store Amvuttra
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the label, tray lid and carton after 'EXP'. The expiry date refers to the last day of that month. Do not store above 30 °C. Do not freeze. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6.
How to store it
Amvuttra Do not store above 30°C. Do not freeze. Keep this medicine out of the sight and reach of children. Important Warnings Do not use if the carton is damaged or shows signs of tampering. Do not use the syringe if it was dropped on a hard surface. Do not touch the plunger rod until ready to inject. Do not remove the needle cap until just before injection. Do not recap the syringe at any time.
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How the syringe looks before and after use: Before Use
After Use
Needle cap Needle
Syringe body
Drug solution
Needle shield (Locked)
Syringe label Finger flange
Thumb pad
Plunger rod
Step 1: Gather Supplies Gather and place the following supplies (not supplied) on a clean flat surface:
- Alcohol wipe
- Gauze pad or cotton ball
- Adhesive bandage
- Sharps container
Step 2: Prepare the Syringe If stored cold, allow the syringe to warm to room temperature for at least 30 minutes before use. Do not warm syringe in any other way, e.g., microwave, hot water, or near other heat sources. Remove the syringe from the packaging by gripping the syringe body. Do not touch plunger rod until ready to inject. 7
Do not use the syringe if it was dropped on a hard surface. Do not remove the needle cap until just before injection. Step 3: Inspect Syringe Check: ✓ Syringe is not damaged, such as cracked or leaking. ✓ Needle cap is intact and attached to the syringe. ✓ The drug solution in the syringe is clear, and colourless-to-yellow. ✓ "Amvuttra 25 mg" appears on the syringe label. ✓ Expiration date on syringe label. It is normal to see air bubbles inside the syringe. Do not use the syringe if any issues are found while checking the syringe and drug solution. Do not use if the expiry date has passed. Do not use if the drug solution contains particulate matter or if it is cloudy or discoloured. Contact healthcare provider if any issues are found. Step 4: Choose Site for Injection Choose an injection site from the following areas: • • •
Abdomen, except for the 5 cm (2 inches) area around the belly button (navel). Front of the thighs. If someone else is giving the injection, then the back of the upper arms can be used as well. Do not inject into areas of skin that are tender, red, swollen, bruised or hard or within 5 cm (2 inches) of the belly button (navel).
Step 5: Prepare for Injection Wash hands with soap and water and dry thoroughly with a clean towel.
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Clean the chosen injection site using an alcohol wipe. Allow the skin to air dry before injecting. Avoid touching or blowing on the injection site after cleaning. Step 6: Remove Needle Cap Hold the syringe body with one hand. Pull the needle cap straight off with the other hand and dispose of needle cap immediately. It is normal to see a drop of liquid at the tip of the needle. Do not touch the needle or let it touch any surface. Do not recap the syringe. Do not pull on plunger rod. Do not use the syringe if it was dropped on a hard surface. Step 7: Insert Needle Using the free hand, gently pinch the cleaned skin around the injection site to create a bump for the injection. Fully insert the needle into the pinched skin at a 45-90° degree angle.
Step 8: Inject Medication Using the thumb pad, push the plunger rod while grasping the finger flange.
Push the plunger rod all the way down, as far as it will go, to inject all of the drug solution. The plunger rod must be pressed all the way down to administer the dose.
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Step 9: Release Plunger Rod Release the plunger rod to cover the needle. Remove syringe from skin. Do not block plunger rod movement. Do not pull down on the needle shield. The needle shield automatically covers the needle. Step 10: Check Injection Site There may be a small amount of blood or liquid at the injection site. If so, apply pressure over the injection site with a gauze pad or cotton ball until any bleeding stops. Avoid rubbing the injection site. Step 11: Dispose of Syringe Immediately dispose of the used syringe into a sharps container. Only use a sharps container to dispose of syringes.
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Contents of the pack and other information
What Amvuttra contains • The active substance is vutrisiran. Each pre-filled syringe contains vutrisiran sodium equivalent to 25 mg vutrisiran in 0.5 mL solution. • The other ingredients are: sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride and water for injections. Sodium hydroxide and phosphoric acid may be used to adjust the pH (see "Amvuttra contains sodium" in section 2). What Amvuttra looks like and contents of the pack This medicine is a clear, colourless-to-yellow solution for injection (injection). Each pack contains one single-use pre-filled syringe. Marketing Authorisation Holder and Manufacturer Alnylam Netherlands B.V. Antonio Vivaldistraat 150 1083 HP Amsterdam Netherlands For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: United Kingdom Alnylam UK Ltd. Tel: 08001412569 (+44 1628 878592) [email protected]
This leaflet was last revised in
July 2025
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INSTRUCTIONS FOR USE Amvuttra 25 mg solution for injection in pre-filled syringe vutrisiran Single-Dose Pre-filled Syringe with Needle Shield
Read these instructions before using this pre-filled syringe. Understanding the pre-filled syringe The pre-filled syringe (referred to as the "syringe") is disposable and for single-use only. Route and method of administration Each carton contains one Amvuttra single use syringe. Each Amvuttra syringe contains 25 mg of vutrisiran for injection under the skin (subcutaneous injection) once every 3 months. Your doctor or healthcare provider will show you and/or your caregiver how to prepare and inject a dose of Amvuttra before you do it yourself. Contact your healthcare professional or doctor for further guidance and support if needed. Keep these instructions until the syringe has been used.
Frequently asked questions about Amvuttra 25 mg solution for injection in pre-filled syringe
How do I take Amvuttra 25 mg solution for injection in pre-filled syringe?
Amvuttra 25 mg solution for injection in pre-filled syringe comes as injection containing 25mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Amvuttra 25 mg solution for injection in pre-filled syringe?
The active substance in Amvuttra 25 mg solution for injection in pre-filled syringe is vutrisiran sodium.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Amvuttra 25 mg solution for injection in pre-filled syringe, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Amvuttra 25 mg solution for injection in pre-filled syringe without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: vutrisiran sodium
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Amvuttra is indicated for the treatment of hereditary transthyretin amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy (hATTR-PN).
Amvuttra is indicated for the treatment of wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM).
4.2. Posology and method of administration
Therapy should be initiated under the supervision of a physician knowledgeable in the management of amyloidosis. Treatment should be started as early as possible in the disease course to prevent the accumulation of disability.
Posology
The recommended dose of Amvuttra is 25 mg administered via subcutaneous injection once every 3 months.
Vitamin A supplementation at approximately, but not exceeding, 2500 IU to 3000 IU vitamin A per day is advised for patients treated with Amvuttra (see section 4.4).
The decision to continue treatment in those patients whose disease progresses to stage 3 polyneuropathy should be taken at the discretion of the physician based on the overall benefit and risk assessment.
There is limited data with vutrisiran in patients with New York Heart Association (NYHA) Class IV and in patients who have both NYHA Class III and National Amyloidosis Centre (NAC) stage III. However, if patients on vutrisiran progress to these stages, these data suggest that patients can remain on treatment.
Missed dose
If a dose is missed, Amvuttra should be administered as soon as possible. Dosing should be resumed every 3 months, from the most recently administered dose.
Special populations
Elderly patients
No dose adjustment is required in patients ≥ 65 years of age (see section 5.2).
Hepatic impairment
No dose adjustment is necessary in patients with mild (total bilirubin ≤ 1 x upper limit of normal (ULN) and aspartate aminotransferase (AST) > 1 x ULN, or total bilirubin > 1.0 to 1.5 x ULN and any AST) or moderate (total bilirubin > 1.5 to 3 x ULN and any AST) hepatic impairment. Vutrisiran has not been studied in patients with severe hepatic impairment and should only be used in these patients if the anticipated clinical benefit outweighs the potential risk (see section 5.2).
Renal impairment
No dose adjustment is necessary in patients with mild or moderate renal impairment (estimated glomerular filtration rate [eGFR] ≥ 30 to < 90 mL/min/1.73 m2). Vutrisiran has not been studied in patients with severe renal impairment or end-stage renal disease and should only be used in these patients if the anticipated clinical benefit outweighs the potential risk (see section 5.2).
Paediatric population
The safety and efficacy of Amvuttra in children or adolescents < 18 years of age have not been established. No data are available.
Method of administration
Amvuttra is for subcutaneous use only.
Amvuttra may be administered by a healthcare professional, the patient, or a caregiver.
Patients or caregivers may inject Amvuttra after guidance has been provided by a healthcare professional on proper subcutaneous injection technique.
This medicinal product is ready-to-use and for single-use only.
Visually inspect the solution for particulate matter and discolouration. Do not use if discoloured or if particles are present.
Prior to administration, if stored cold, the pre-filled syringe should be allowed to warm by leaving carton at room temperature for about 30 minutes.
• The subcutaneous injection should be administered into one of the following sites: the abdomen, thighs, or upper arms. If injected in the upper arm, the injection should be administered by a healthcare professional or a caregiver. Amvuttra should not be injected into scar tissue or areas that are reddened, inflamed, or swollen.
• If injecting into the abdomen, the area around the navel should be avoided.
4.3. Contraindications
Severe hypersensitivity (e.g., anaphylaxis) to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Vitamin A deficiency
By reducing serum transthyretin (TTR) protein, Amvuttra treatment leads to a decrease in serum vitamin A (retinol) levels (see section 5.1). Serum vitamin A levels below the lower limit of normal should be corrected and any ocular symptoms or signs due to vitamin A deficiency should be evaluated prior to initiation of treatment with Amvuttra.
Patients receiving Amvuttra should take oral supplementation of approximately, but not exceeding, 2500 IU to 3000 IU vitamin A per day to reduce the potential risk of ocular symptoms due to vitamin A deficiency. Ophthalmological assessment is recommended if patients develop ocular symptoms suggestive of vitamin A deficiency, including reduced night vision or night blindness, persistent dry eyes, eye inflammation, corneal inflammation or ulceration, corneal thickening or corneal perforation.
During the first 60 days of pregnancy, both too high or too low vitamin A levels may be associated with an increased risk of foetal malformation. Therefore, pregnancy should be excluded before initiating Amvuttra and women of childbearing potential should practise effective contraception (see section 4.6). If a woman intends to become pregnant, Amvuttra and vitamin A supplementation should be discontinued and serum vitamin A levels should be monitored and have returned to normal before conception is attempted. Serum vitamin A levels may remain reduced for more than 12 months after the last dose of Amvuttra.
In the event of an unplanned pregnancy, Amvuttra should be discontinued (see section 4.6). No recommendation can be given whether to continue or discontinue vitamin A supplementation during the first trimester of an unplanned pregnancy. If vitamin A supplementation is continued, the daily dose should not exceed 3000 IU per day, due to the lack of data supporting higher doses. Thereafter, vitamin A supplementation of 2500 IU to 3000 IU per day should be resumed in the second and third trimesters if serum vitamin A levels have not yet returned to normal, because of the increased risk of vitamin A deficiency in the third trimester.
It is not known whether vitamin A supplementation in pregnancy will be sufficient to prevent vitamin A deficiency if the pregnant female continues to receive Amvuttra. However, increasing vitamin A supplementation to above 3000 IU per day during pregnancy is unlikely to correct plasma retinol levels due to the mechanism of action of Amvuttra and may be harmful to the mother and foetus.
Sodium content
This medicinal product contains less than 1 mmol sodium (23 mg) per mL, that is to say essentially 'sodium-free'.
4.5. Interaction with other medicinal products and other forms of interaction
No clinical interaction studies have been performed. Vutrisiran is not expected to cause interactions or to be affected by inhibitors or inducers of cytochrome P450 enzymes, or to modulate the activity of transporters. Therefore, vutrisiran is not expected to have clinically significant interactions with other medicinal products.
4.6. Fertility, pregnancy and lactation
Women of childbearing potential
Treatment with Amvuttra reduces serum levels of vitamin A. Both too high or too low vitamin A levels may be associated with an increased risk of foetal malformation. Therefore, pregnancy should be excluded before initiation of treatment and women of childbearing potential should use effective contraception. If a woman intends to become pregnant, Amvuttra and vitamin A supplementation should be discontinued and serum vitamin A levels should be monitored and have returned to normal before conception is attempted (see section 4.4.). Serum vitamin A levels may remain reduced for more than 12 months after the last dose of treatment.
Pregnancy
There are no data on the use of Amvuttra in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). Due to the potential teratogenic risk arising from unbalanced vitamin A levels, Amvuttra should not be used during pregnancy. As a precautionary measure, vitamin A (see section 4.4) and thyroid stimulating hormone levels should be obtained early in pregnancy. Close monitoring of the foetus should be carried out, especially during the first trimester.
Breast-feeding
It is unknown whether vutrisiran is excreted in human milk. There is insufficient information on the excretion of vutrisiran in animal milk (see section 5.3).
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Amvuttra, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility
There are no data on the effects of Amvuttra on human fertility. No impact on male or female fertility was detected in animal studies (see section 5.3).
4.7. Effects on ability to drive and use machines
Amvuttra has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Tabulated list of adverse reactions
The safety profile of Amvuttra was characterised based on the data from randomised-controlled phase 3 clinical studies. Adverse reactions reported in the pooled dataset of HELIOS-A and HELIOS-B studies are presented in Table 1. The adverse reactions are presented as MedDRA preferred terms and under the MedDRA System Organ Class (SOC). The frequency of the adverse reactions is expressed according to the following category:
Common (≥1/100 to <1/10).
Table 1: Adverse reactions reported for Amvuttra
System Organ Class
Adverse Reaction
Frequency
General disorders and administration site conditions
Injection site reactiona
Common
Investigations
Alanine transaminase increased
Common
Blood alkaline phosphatase increased
Common
a Reported symptoms included bruising, erythema, pain, pruritus, and warmth. Injection site reactions were mild, transient, and did not lead to treatment discontinuation
Description of selected adverse reactions
Liver function tests
In the HELIOS-B study, 97 (30%) of patients treated with Amvuttra and 78 (24%) patients treated with placebo had a mild increased alanine aminotransferase (ALT) greater than the ULN and less than or equal to 3×ULN. All patients treated with Amvuttra with mild ALT elevations were asymptomatic and the majority had normalization of ALT levels with continued dosing.
Immunogenicity
In the HELIOS-A and HELIOS-B studies, 4 (3.3%) and 1 (0.3%) Amvuttra-treated patients, respectively, developed anti-drug antibodies (ADA). In both studies, ADA titres were low and transient with no evidence of an effect on clinical efficacy, safety, or pharmacokinetic or pharmacodynamic profiles of vutrisiran.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system:
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
or search for MHRA Yellow Card in the Google Play or Apple App Store
4.9. Overdose
In case of overdose, it is recommended that the patient be monitored as medically indicated for any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- AMVUTTRA 25 mg prescriptionVUTRISIRANUM · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- AmvuttraVutrisiranum · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Amvuttra 25 mg solution for injection in pre-filled syringe. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.