Cápsulas de Fingolimode
Gilenya
Revisado por Sid DajaniÚltima atualização por Michael Stewart, MRPharmSLast updated 9 de Nov de 2023
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Clinical author's note: Michael Stewart 25/01/2021: the Medicines and Healthcare products Regulatory Agency (MHRA) has issued new advice for doctors and patients following reports of serious liver injury in a small number of people taking fingolimod. Your doctor will arrange for regular blood tests during your treatment to monitor your liver function. Seek urgent medical attention if you develop any symptoms or signs of liver injury, such as feeling sick (nausea) or being sick (vomiting), tiredness, abdominal (tummy) pain, yellow skin or eyes, or dark urine.
Clinical author's note: Michael Stewart 23/9/2019: the Medicines and Healthcare products Regulatory Agency (MHRA) has issued a new warning regarding an increased risk of birth defects if fingolimod is taken during pregnancy. Pregnant women should not take fingolimod. Women of childbearing potential must use effective contraception during treatment with fingolimod and for two months afterwards. Speak with your doctor if you are planning to become pregnant or think you may be pregnant whilst taking fingolimod.
Fingolimod is a treatment for relapsing-remitting multiple sclerosis (MS) in adults.
Take one (500 microgram) capsule every day.
Side-effects include a slow heart rate at first, an increased risk of infection, and eye problems.
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About fingolimod
Tipo de medicamento | An immunomodulating medicine |
Usado para | Relapsing-remitting multiple sclerosis (MS) in adults and in children aged 10 years or older |
Também chamado de | Gilenya® |
Disponível como | Cápsulas |
Multiple sclerosis (MS) is a condition which affects the brain and spinal cord. The protective cover around nerves in the brain and spinal cord is damaged in people with MS, and this stops the nerves from working as they should. Most people with MS have the relapsing-remitting form of the disease where symptoms come and go in episodes. A 'relapse' occurs when an episode of symptoms develops. The symptoms last for a period of time and then ease, or 'remit'. Further relapses occur from time to time, with periods of remission in between.
Fingolimod works by interfering with your immune system, because it is believed that this is responsible for causing the damage to the nerves. Fingolimod reduces the access of certain white blood cells to the brain and spinal cord, and this reduces the number of relapses in some people. Fingolimod does not cure MS, and it is not a suitable treatment for everyone. It will be prescribed for you by a specialist and your treatment will be closely monitored.
Before taking fingolimod
Voltar ao conteúdoSome medicines are not suitable for people with certain conditions, and sometimes a medicine may only be used if extra care is taken. For these reasons, before you start taking fingolimod it is important that your doctor knows:
Se você está grávida ou amamentando.
If you have a condition which affects your immune system.
Se lhe foi dito que você tem um ritmo cardíaco irregular.
If you have any other heart problem, including angina pain or if you have had a heart attack in the past.
If you have blood vessel disease or if you have had a stroke or transient ischaemic attack (TIA) in the past.
Se você tem um problema com o funcionamento do seu fígado.
If you have any problems with your lungs or breathing.
If you are currently unwell, or have an infection or a high temperature (fever).
If you have been told you have cancer.
Se você já teve uma reação alérgica a um medicamento.
Se você estiver tomando outros medicamentos. Isso inclui quaisquer medicamentos que você esteja tomando e que estejam disponíveis para compra sem receita médica, bem como medicamentos fitoterápicos e complementares.
Nota do autor clínico (Michael Stewart) 18/12/2017: this leaflet has been updated to reflect a recent drug safety update from MHRA which issued additional advice for healthcare professionals with regard to patients with heart arrhythmias and other heart problems.
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How to take fingolimod
Voltar ao conteúdoBefore you start this treatment, read the manufacturer's printed information leaflet from inside your pack. It will give you more information about fingolimod and will provide you with a full list of the side-effects which you may experience from taking it.
You will be asked to take your first dose of fingolimod in a clinic where you can be observed. This is because it can slow your heart rate at first, and your doctor will want to check for this.
Take fingolimod exactly as your doctor tells you to. Take one capsule a day. Try to take your doses at the same time of day each day, as this will help you to remember to take fingolimod regularly.
Swallow the capsule with a drink of water. You can take fingolimod before or after meals.
Your doctor will give you instructions in case you forget to take a dose. You must follow the directions your doctor gives to you, but as a guide, the usual recommendation is that if you have been taking fingolimod for less than a month and you miss a dose, you should speak with your doctor antes you take the next dose.
Obtendo o máximo do seu tratamento
Voltar ao conteúdoRemember to keep all your regular appointments with your doctor. This is so your doctor can check on your progress. You will need to have regular blood tests and skin and eye checks during the treatment.
Fingolimod can harm an unborn child so you must avoid getting pregnant while you are taking it. Make sure you have discussed with your doctor which types of contraception are suitable for you and your partner. You must use effective contraception during treatment and for two months afterwards. If you are a woman and want to have a family, discuss this with your doctor so that you can be given advice from a specialist before you become pregnant.
If you are due to have any vaccinations, it is very important that the person treating you knows that you are taking this medicine. This is because fingolimod will make some vaccines less effective, and also because you will be at risk of getting an infection from some vaccines.
Fingolimod can cause your skin to become more sensitive to sunlight than normal. Protect your skin from sunlight even on bright but cloudy days and do not use sunbeds. Let your doctor know straightaway if you notice any changes to your skin.
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Can fingolimod cause problems?
Voltar ao conteúdoAlong with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them. The table below contains some of the most common ones associated with fingolimod. You will find a full list in the manufacturer's information leaflet supplied with your medicine. The unwanted effects often improve as your body adjusts to the new medicine, but speak with your doctor or pharmacist if any of the following continue or become troublesome.
Common fingolimod side-effects | O que posso fazer se passar por isso? |
Infections (in particular nose, throat and lung infections), cough | Let your doctor know if you notice any signs of infection |
Feeling dizzy or tired, blurred vision | Não dirija e não use ferramentas ou máquinas enquanto estiver afetado |
Dor de cabeça, dor nas costas | Ask your doctor or pharmacist to recommend a suitable painkiller. If the headache is sudden or severe, speak with your doctor straightaway |
Diarreia | Beba bastante água |
Low mood, skin problems | Converse com seu médico se houver problemas |
Slow heart rate, changes to some blood test results, blood pressure changes, weight loss | Seu médico verificará estes |
Importante: There have been rare reports of serious liver injury in a small number of people taking fingolimod. Your doctor will arrange for blood tests during your treatment, however, seek urgent medical attention if you develop a combination of the following symptoms:
Sentindo-se mal (náusea) ou vomitando (vômito)
Cansaço
Abdominal (tummy) pain
Yellowing skin or eyes, or dark urine.
You should also let your doctor know immediately if you experience any signs of infection such as:
Headache or neck stiffness
Rash or high temperature (fever)
Oversensitivity to light
Se você sentir quaisquer outros sintomas que acha que podem ser devido às cápsulas, fale com seu médico ou farmacêutico para mais orientações.
Nota do autor clínico (Michael Stewart) 25/01/2021: this leaflet has been updated to reflect drug safety updates from the MHRA regarding serious liver injury, pregnancy, sensitivity to UV light and signs of infection.
How to store fingolimod
Voltar ao conteúdoMantenha todos os medicamentos fora do alcance e da vista das crianças.
Armazene em local fresco e seco, longe de calor e luz diretos.
Informações importantes sobre todos os medicamentos
Voltar ao conteúdoInformações importantes sobre todos os medicamentos
Nunca tome mais do que a dose prescrita. Se suspeitar que você ou outra pessoa possa ter tomado uma overdose deste medicamento, vá ao departamento de acidentes e emergências do hospital local. Leve o recipiente com você, mesmo que esteja vazio.
Se você estiver prestes a fazer uma operação ou tratamento dentário, informe à pessoa que realizará o tratamento quais medicamentos você está tomando.
If you buy any medicines, always check with your doctor or a pharmacist that they are suitable for you to take.
Este medicamento é para você. Nunca o dê a outras pessoas, mesmo que a condição delas pareça ser a mesma que a sua.
Não guarde medicamentos vencidos ou indesejados. Leve-os à sua farmácia local, que se encarregará de descartá-los para você.
Se você tiver alguma dúvida sobre este medicamento, pergunte ao seu farmacêutico.
MHRA - Relatando reações adversas
Relate efeitos colaterais suspeitos de medicamentos, vacinas, cigarros eletrônicos, incidentes com dispositivos médicos, produtos defeituosos ou falsificados (falsos) à Agência Reguladora de Medicamentos e Produtos de Saúde para garantir o uso seguro e eficaz.

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Leitura adicional e referências
- Manufacturer's PIL, Gilenya® 0.25 mg and 0.5 mg hard capsules; Novartis Pharmaceuticals UK Ltd, The electronic Medicines Compendium. Dated May 2023.
- Medicamentos Completo BNF 89ª Edição; Associação Médica Britânica e Sociedade Real de Farmácia da Grã-Bretanha, Londres.
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About the authorView full bio

Michael Stewart, MRPharmS
Gerente de Revisão de Folhetos de Medicamentos – Contratado, Farmacêutico
BPharm (Hons), MRPharmS
Michael é um farmacêutico comunitário atuando nas Midlands e em South Yorkshire, com mais de 20 anos de experiência em aconselhamento sobre medicamentos e condições médicas. Ele tem uma sólida formação em treinamento em saúde, tendo produzido e ministrado cursos de treinamento para equipes de farmácia e funcionários de ambientes de cuidados residenciais, incluindo enfermeiros. Ele também contribuiu para conselhos consultivos de farmácia para o manejo de condições de baixa gravidade na comunidade.
About the reviewer

Sid Dajani
Sultan Dajani qualified at the London School of Pharmacy in 1994 and became the youngest elected member of the Royal Pharmaceutical Society council since its founding in 1842.
Histórico do artigo
As informações nesta página são escritas e revisadas por clínicos qualificados.
Próxima revisão agendada: 8 de nov de 2026
9 de Nov de 2023 | Última versão

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