Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Rhapsido contains the active substance remibrutinib, which belongs to a group of medicines called Bruton's tyrosine kinase (BTK) inhibitors.
Rhapsido is used to treat adults with chronic (long-term) spontaneous urticaria (CSU) when treatment with antihistamines does not work well enough.
In people with CSU, symptoms can happen when the immune system (the body's natural defences) becomes overactive. Certain immune cells switch on a protein called Bruton's tyrosine kinase, which causes hives, itching and/or swelling. Remibrutinib works by blocking BTK which helps stop the immune cells from becoming overactive and reduces inflammation, making CSU symptoms less frequent and less severe.
Do not take Rhapsido - if you are allergic to remibrutinib or any of the other ingredients of this medicine (listed in section 6).
Rhapsido 25 mg film-coated tablets
Warnings and precautions Talk to your doctor or pharmacist before taking Rhapsido: - if you have or have ever had unusual bruising or bleeding, or are taking any medicines that could increase your risk of bleeding. See section "Other medicines and Rhapsido" below. - if you have recently had any surgery or are planning to have surgery. Your doctor may ask you to stop taking Rhapsido for a short time before (3 to 7 days) and after (3 to 7 days) your surgery. - if you have recently had a vaccination or are planning to have a vaccination. Certain types of vaccines (known as live or live-attenuated vaccines) are not recommended to be used during
treatment with Rhapsido. If you have had, or are planning to have another type of vaccine (known as a non-live vaccine), your doctor may ask you to stop taking Rhapsido for 1 week before and 2 weeks after the vaccination. - if you are taking any other medicines as these could interact with Rhapsido. See section "Other medicines and Rhapsido" below.
Children and adolescents Do not give this medicine to children or adolescents below 18 years of age. It has not been studied in this age group.
Other medicines and Rhapsido Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Rhapsido may make you bleed more easily. This means you should tell your doctor if you take any other medicines or supplements that increase your risk of bleeding (see "Warnings and precautions" above). This includes any of the following: - medicines used to relieve pain, reduce fever or prevent blood clots, such as acetylsalicylic acid. - medicines used to treat blood clots, such as clopidogrel. - medicines used to thin the blood, such as warfarin.
Tell your doctor or pharmacist if you are taking any of the following medicines as they may increase the risk of side effects of Rhapsido, or Rhapsido may increase the risk of side effects of them: - medicines used to treat HIV infection, such as ritonavir. - medicines used to treat heart problems, such as digoxin. - medicines used to treat high cholesterol, such as rosuvastatin. - medicines used for sedation or sleep disturbances, such as midazolam.
Tell your doctor or pharmacist if you are taking any of the following medicines as they may decrease the effectiveness of Rhapsido: - medicines used to treat certain types of seizures, such as carbamazepine.
Tell your doctor or pharmacist if you have recently had a vaccination or plan to have a vaccination (see "Warnings and precautions" above).
Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Treatment with Rhapsido is not recommended during pregnancy or in women who can become pregnant who are not using effective contraception (birth control). This is because studies in animals have shown that Rhapsido may cause harm to the unborn baby.
Do not breast-feed during treatment with Rhapsido and for one week after stopping treatment, as it is not known if Rhapsido passes into breast milk.
If you are a woman who could become pregnant, you must use an effective method of contraception (birth control) during treatment with Rhapsido and for at least one week after stopping treatment. Ask your doctor about effective methods of contraception.
Driving and using machines Rhapsido has no or negligible influence on the ability to drive and use machines.
Rhapsido contains sodium This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially "sodium-free".
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is one 25 mg tablet twice a day, once in the morning and once in the evening.
- Swallow the tablet whole with water. - Do not split, crush or chew the tablet before swallowing as this may change how much medicine gets into your body. - To help you remember to take Rhapsido, take it at the same time every day. - Rhapsido can be taken with or without food.
Rhapsido and surgery Tell your doctor if you have recently had surgery or plan to have surgery. Your doctor may ask you to stop taking Rhapsido for 3 to 7 days before and 3 to 7 days after any planned medical or surgical procedures.
If you take more Rhapsido than you should If you take more Rhapsido than you should, talk to a doctor straight away. If you are told to go to the hospital, take the tablet pack and this leaflet with you.
If you forget to take Rhapsido If you miss a dose then you should take the next dose at your usual time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Rhapsido Stopping your treatment with Rhapsido may cause your CSU symptoms to return. Do not stop taking Rhapsido unless your doctor tells you to.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
All of the following side effects are mild to moderate.
Very common (may affect more than 1 in 10 people) - Nose and throat infections (upper respiratory tract infections)
Common (may affect up to 1 in 10 people) - Herpes virus infection - Headache - Bruising - Tiny red spots under the skin (petechiae) - Bruising under the skin (contusion) - A bleeding spot under the skin with blue or purplish patch (ecchymosis) - Pink or brown urine/blood in the urine (haematuria) - Feeling sick (nausea) - Abdominal pain - Back pain - Fever (pyrexia)
Uncommon (may affect up to 1 in 100 people) - Nosebleed (epistaxis)
- Purple or red-brown spots on the skin (purpura) - A flat, bright red patch in the white of the eye (conjunctival bleeding) - Bleeding gums (gingival bleeding)
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 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.
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 carton and the blister foil after "EXP". The expiry date refers to the last day of that month.
Store in the original package in order to protect from moisture.
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.
What Rhapsido contains - The active substance is remibrutinib. Each film-coated tablet contains 25 mg of remibrutinib. - The other ingredients are mannitol, microcrystalline cellulose, copovidone, croscarmellose sodium, sodium stearyl fumarate, sodium lauryl sulfate. The tablet coating is composed of polyvinyl alcohol, macrogol 4000, talc, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).
What Rhapsido looks like and contents of the pack Rhapsido is supplied as 25 mg film-coated tablets. The tablets are light yellow, round and curved. They have "LV" on one side and the company logo on the other side. The tablet diameter is approximately 7 mm.
Rhapsido is supplied in blisters and is available in packs containing 30, 60 or 180 film-coated tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building White City Place, 195 Wood Lane London, W12 7FQ United Kingdom Manufacturer Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building White City Place, 195 Wood Lane London, W12 7FQ United Kingdom Novartis Pharmaceutical Manufacturing LLC
Verovskova Ulica 57 1000 Ljubljana Slovenia
Novartis Pharma GmbH Sophie-Germain-Strasse 10 90443 Nuremberg Germany
Novartis Farmaceutica S.A. Gran Via de les Corts Catalanes 764 08013 Barcelona Spain
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: United Kingdom Novartis Pharmaceuticals UK Ltd. Tel: +44 1276 698370
This leaflet was last revised in July 2026.
Rhapsido 25 mg Film-coated Tablet comes as tablet containing 25 mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Rhapsido 25 mg Film-coated Tablet is remibrutinib.
This leaflet reproduces the patient information leaflet approved for Rhapsido 25 mg Film-coated Tablet, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
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.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Rhapsido is indicated for the treatment of chronic spontaneous urticaria (CSU) in adult patients with inadequate response to H1 antihistamine treatment.
Treatment should be initiated by physicians experienced in the diagnosis and treatment of chronic spontaneous urticaria.
Posology
The recommended dose of remibrutinib is 25 mg taken orally twice daily, once in the morning and once in the evening.
If a patient misses one or more doses of remibrutinib, the patient should be instructed to take the next dose at its regularly scheduled time. Extra doses of remibrutinib should not be taken to make up for the missed dose or doses.
Prescribers are advised to periodically reassess the need for continued therapy. Consideration should be given to discontinuing treatment in patients who have shown no response after 24 weeks of treatment for CSU.
Dose interruption
It is recommended to interrupt remibrutinib for 3 to 7 days before surgery and for 3 to 7 days after surgery depending upon the type of surgery and the risk of bleeding (see sections 4.4, 4.5 and 4.8).
Special populations
Elderly
No specific dose adjustment is required for elderly patients (aged ≥65 years) (see section 5.2). Limited data are available on the use of remibrutinib in patients older than 65 years.
Renal impairment
No dose adjustment is required in patients with renal impairment (see section 5.2).
Hepatic impairment
No dose adjustment is required in patients with mild or moderate hepatic impairment. Remibrutinib is not recommended for use in patients with severe hepatic impairment (see section 5.2).
Paediatric population
Rhapsido should not be used in infants and children below 6 years of age because of the unknown potential impact on humoral immunity maturation (e.g. generation of protective immunoglobulins and memory B cells).
The safety and efficacy of remibrutinib in children and adolescents 6 to 18 years of age have not been established. No data are available.
Method of administration
Oral use.
Remibrutinib may be taken with or without food. Patients should be instructed to swallow the tablet whole with water. The tablets should not be split, crushed or chewed to ensure the entire dose is delivered correctly.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Remibrutinib is primarily metabolised by CYP3A4.
Active substances that may increase remibrutinib blood concentrations
CYP3A4 inhibitors
Co-administration of remibrutinib with strong CYP3A4 inhibitors must be avoided. Co-administration of ritonavir, a strong CYP3A4/P-gp inhibitor, led to a 4.3-fold increase in the AUC and a 3.3-fold increase in the Cmax of remibrutinib.
Active substances that may decrease remibrutinib blood concentrations
CYP3A4 inducers
Co-administration of remibrutinib with strong or moderate CYP3A4 inducers must be avoided. Co-administration of carbamazepine (strong to moderate CYP3A4 inducer) decreased the remibrutinib blood exposure by 74% (Cmax) and 78% (AUC).
Active substances whose plasma concentrations may be altered by remibrutinib
Transport substrates/inhibitors
It is recommended to monitor patients more frequently for potential adverse reactions when using remibrutinib with P-gp and BCRP substrates with a narrow therapeutic index, especially where minimal concentration changes can lead to adverse reactions. Co-administration of digoxin (a P-gp substrate with a narrow therapeutic index) with remibrutinib led to a 1.4-fold increase in the AUC and a 2.1-fold increase in the Cmax of digoxin. Co-administration of rosuvastatin (a BCRP substrate without a narrow therapeutic index) with remibrutinib led to a 1.7-fold increase in the AUC and a 1.6-fold increase in the Cmax of rosuvastatin.
In a drug-interaction study, the effect of administration of remibrutinib (100 mg twice daily) on the pharmacokinetics of midazolam (a sensitive CYP3A4 substrate) led to a 43% increase in the AUC and a 27% increase in the Cmax of midazolam. The effect of the clinical dose of remibrutinib (25 mg twice daily) was not studied and may be different. Remibrutinib should not be used with concomitant administration of CYP3A4 substrates that have narrow therapeutic indices (e.g. ciclosporin, tacrolimus, digoxin, warfarin, carbamazepine).
Oral contraceptives
Co-administration of remibrutinib is not expected to have an adverse impact on the efficacy of oral contraceptives containing ethinyloestradiol and levonorgestrel (CYP3A4 substrates) as their exposure was not decreased in the presence of remibrutinib 100 mg twice daily (1.28- and 1.36-fold increase in Cmax and 1.16- and 1.39-fold increase in AUC, respectively).
Effect of remibrutinib on immune response to vaccines
No data are available on the effects of live or live-attenuated vaccines in patients receiving remibrutinib and these vaccines should not be co-administered with remibrutinib (see section 4.4).
Based on a vaccination immune response study in healthy volunteers, non-live vaccines can be given during remibrutinib treatment. To optimise the immune response to non-live vaccines, interruption of remibrutinib treatment should be considered (from 1 week prior to the planned vaccination until 2 weeks after the vaccination).
Vaccination immune response study
In a placebo-controlled study in healthy volunteers using remibrutinib 100 mg twice daily, the immune response to non-live vaccines was not significantly impacted when remibrutinib was interrupted for 1 week before until 2 weeks after vaccination. However, concomitant remibrutinib treatment was associated with a 60% reduction of responders to the T cell-independent polysaccharide PPV23 vaccine, a 21% reduction in IgG response to keyhole limpet haemocyanin (KLH) vaccine (T cell-dependent neoantigen), comparable response rates (1 to 14% reduction) for 3 out of 4 of the antigens in influenza vaccine (T cell-dependent) and a 27% reduction for 1 out of 4 of the influenza antigens.
Effect of remibrutinib on antithrombotic agents
No data are available on co-administration of remibrutinib with anticoagulants. The risks and benefits of co-administration of antithrombotic agents with remibrutinib must be considered (see sections 4.2, 4.4 and 4.8).
Paediatric population
Interaction studies have only been performed in adults.
Women of childbearing potential
Sexually active women of childbearing potential must use effective contraception (methods that result in less than 1% pregnancy rates) during remibrutinib treatment and for at least 1 week after the last dose. Women of childbearing potential must be advised that animal studies have shown remibrutinib to be harmful to the developing foetus (see section 5.3).
Pregnancy
There are limited data from the use of remibrutinib in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Rhapsido is not recommended during pregnancy.
Breast-feeding
It is unknown whether remibrutinib/metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded. Breast-feeding should be discontinued during treatment with remibrutinib and for 1 week after the last dose.
Fertility
There are no data on the effect of remibrutinib on human fertility. No adverse effects on fertility were observed in male and female rats (see section 5.3).
Rhapsido has no or negligible influence on the ability to drive and use machines.
There was no evidence of dose-limiting adverse events seen with remibrutinib at doses up to 600 mg per day in the phase I clinical studies. Signs and symptoms of remibrutinib overdose have not been established and there is no specific treatment for remibrutinib overdose.
In the event of an overdose, the patient should be treated symptomatically, and supportive measures should be instituted as required.
Ask anything about Rhapsido 25 mg Film-coated Tablet. 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.
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