{"id":18530,"date":"2022-02-18T16:41:45","date_gmt":"2022-02-18T16:41:45","guid":{"rendered":"https:\/\/zeepedia.com\/?p=18530"},"modified":"2022-02-19T09:43:35","modified_gmt":"2022-02-19T09:43:35","slug":"myozyme","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/myozyme\/","title":{"rendered":"Myozyme – Alglucosidase alfa uses, dose and side effects"},"content":{"rendered":"\n

50 mg powder for concentrate for solution for infusion alglucosidase
alfa<\/p>\n\n\n\n

What Myozyme is and what it is used for<\/h2>\n\n\n\n

Myozyme is used to treat adults, children, and adolescents of all ages where the diagnosis of\u00a0Pompe disease\u00a0is established.<\/p>\n\n\n\n

People with\u00a0Pompe disease\u00a0have low levels of an\u00a0enzyme\u00a0called alpha-glucosidase.\u00a0This\u00a0enzyme\u00a0helps control glycogen levels (a type of carbohydrate) in the body.\u00a0Glycogen\u00a0provides the body with energy, but if you suffer from\u00a0Pompe disease, glycogen levels can become too high.<\/p>\n\n\n\n

Myozyme contains an artificial\u00a0enzyme\u00a0called alglucosidase alfa which can replace the human\u00a0enzyme\u00a0that is missing in\u00a0Pompe disease.<\/p>\n\n\n\n

What you need to know before you get Myozyme<\/h2>\n\n\n\n

Do not use Myozyme<\/h2>\n\n\n\n

If you have experienced life-threatening allergic (hypersensitivity) reactions to alglucosidase alfa or any of the other ingredients of this medicine (listed in section 6) and if re-administration of the medicine was not successful.\u00a0Symptoms of life-threatening allergic reactions include (but are not limited to) low\u00a0blood pressure, very fast heart rate, difficulty breathing, vomiting, swelling of the face, hives, or rash.<\/p>\n\n\n\n

Warnings and cautions<\/h2>\n\n\n\n

If you are being treated with Myozyme, you may experience an infusion-related\u00a0side effect\u00a0when you receive the medicine or in the next few hours after the\u00a0infusion.\u00a0Such a\u00a0side effect\u00a0can consist of various symptoms such as low\u00a0blood pressure, chest discomfort, swelling of the throat, swelling of the face, lips, or tongue (\u00a0angioedema\u00a0),\u00a0hives\u00a0(\u00a0urticaria\u00a0), dizziness, rash, itchy skin, nausea, vomiting, cough, and\u00a0bronchospasm\u00a0(see section 4 for an overview of all infusion-related\u00a0side effects\u00a0).\u00a0Such an infusion-related\u00a0side effect\u00a0can in some cases be very serious.\u00a0If you experience a similar side effect, you\u00a0should contact a doctor immediately.\u00a0You may need medication before treatment to prevent an\u00a0allergic reaction\u00a0(eg\u00a0antihistamines\u00a0and\/or\u00a0corticosteroids\u00a0) or antipyretics.<\/p>\n\n\n\n

To reduce the production of\u00a0antibodies, doctors in studies have used drugs that inhibit the immune system.\u00a0Because you have\u00a0Pompe disease, there is a risk of getting a serious\u00a0infection\u00a0in the airways or lungs.\u00a0By using drugs that inhibit the immune system, the risk can increase further.<\/p>\n\n\n\n

If you experience severe wound damage to the skin, consult a doctor. If your legs swell or if you feel generally swollen, consult a doctor. Your doctor should consider stopping Myozyme treatment and starting appropriate medical treatment. Your doctor should consider the risks and benefits of reintroducing Myozyme.<\/p>\n\n\n\n

Other medicines and Myozyme<\/h2>\n\n\n\n

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.<\/p>\n\n\n\n

Pregnancy, breastfeeding and fertility<\/h2>\n\n\n\n

There is no experience with the use of Myozyme in pregnant women.\u00a0You should not receive Myozyme during pregnancy unless necessary.\u00a0It is recommended that you stop breastfeeding during treatment with Myozyme.\u00a0Ask your doctor or pharmacist for advice before taking any medicine.\u00a0If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.<\/p>\n\n\n\n

Driving and using machines<\/h2>\n\n\n\n

Use caution when driving or using machines shortly after\u00a0infusion\u00a0of Myozyme.\u00a0You may experience dizziness.<\/p>\n\n\n\n

Myozyme contains sodium<\/h2>\n\n\n\n

This medicine contains less than 1 mmol sodium (23 mg) per vial and is therefore essentially ‘sodium-free’.<\/p>\n\n\n\n

How Myozyme is given<\/h2>\n\n\n\n

You will be given Myozyme by a doctor who has experience in treating patients with\u00a0Pompe disease.<\/p>\n\n\n\n

You will receive a\u00a0dose\u00a0based on your body weight.\u00a0The recommended\u00a0dose\u00a0for Myozyme is 20 mg\/kg body weight every two weeks.<\/p>\n\n\n\n

Use for children and adolescents<\/h2>\n\n\n\n

The recommended dose for children and adolescents is the same as for adults.<\/p>\n\n\n\n

Instructions for proper use<\/strong><\/p>\n\n\n\n

Myozyme is given by a drip into a vein (as an\u00a0intravenous\u00a0infusion\u00a0).\u00a0It is supplied in powder form and must be mixed with sterile water before use.<\/p>\n\n\n\n

If you take more Myozyme than you should<\/h2>\n\n\n\n

There is no experience with Myozyme overdose.<\/p>\n\n\n\n

If you forget to use Myozyme<\/h2>\n\n\n\n

If you have missed an\u00a0infusion, consult your doctor.<\/p>\n\n\n\n

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.<\/p>\n\n\n\n

Possible side effects<\/h2>\n\n\n\n

Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n

Adverse reactions\u00a0were mainly reported when patients were being treated or shortly thereafter (infusion-related\u00a0adverse reactions\u00a0).\u00a0Some of these\u00a0side effects\u00a0are serious or life-threatening.\u00a0Life-threatening\u00a0side effects, including very severe generalized allergic reactions and anaphylactic\u00a0shock, have been reported in some patients.\u00a0Symptoms of such reactions include low\u00a0blood pressure, very fast heart rate, difficulty breathing, vomiting, swelling of the face, lips, or tongue, hives, or rash.\u00a0Some patients have experienced\u00a0side effects\u00a0with\u00a0flu-like symptoms\u00a0associated with the\u00a0infusion one.\u00a0The symptoms persisted for a few days after the end of the\u00a0infusion.\u00a0If you get a similar\u00a0side effect, contact your\u00a0doctor immediately.\u00a0You may need medication before treatment to prevent an\u00a0allergic reaction\u00a0(eg\u00a0antihistamines\u00a0and\/or\u00a0corticosteroids\u00a0) or antipyretics.<\/p>\n\n\n\n

Very common: may affect more than 1 in 10 people<\/strong><\/p>\n\n\n\n

  • hives<\/li>
  • rash<\/li>
  • increased heart rate<\/li>
  • flushing<\/li>
  • fever or elevated body temperature<\/li>
  • cough<\/li>
  • faster breathing<\/li>
  • vomiting<\/li>
  • low oxygen level in the blood<\/li><\/ul>\n\n\n\n

    Common: may affect up to 1 in 10 people<\/strong><\/p>\n\n\n\n

    • pallor<\/li>
    • high or high blood pressure<\/li>
    • bluish discoloration of the skin<\/li>
    • overindulge<\/li>
    • indignation<\/li>
    • tremors<\/li>
    • headache<\/li>
    • knitting<\/li>
    • pain or local reactions at the infusion site<\/li>
    • dizziness<\/li>
    • irritability<\/li>
    • itching<\/li>
    • nausea<\/li>
    • swollen face, swollen throat or severe, combined swelling of the face, throat or tongue due to a severe allergic reaction<\/li>
    • swelling in arms and legs<\/li>
    • nausea<\/li>
    • chest discomfort<\/li>
    • tightness in the throat<\/li>
    • diarrhea<\/li>
    • fatigue<\/li>
    • muscle pain<\/li>
    • muscle spasms<\/li>
    • severe wound damage to the skin<\/li>
    • reddening of the skin<\/li><\/ul>\n\n\n\n

      No known frequency: can not be calculated from the available data.<\/strong><\/p>\n\n\n\n

      • swelling around the eyes<\/li>
      • abnormal breathing sounds, including a whistling sound<\/li>
      • difficulty breathing (including shortness of breath)<\/li>
      • cold in the extremities (eg hands, feet)<\/li>
      • low blood pressure<\/li>
      • narrowed blood vessels that reduce blood flow<\/li>
      • sudden contraction of the bronchi which limits the amount of air that passes into and out of the lungs (bronchospasm)<\/li>
      • feeling of warmth<\/li>
      • sweating<\/li>
      • increased tear flow<\/li>
      • mottled skin<\/li>
      • restlessness<\/li>
      • wheezing breathing sounds<\/li>
      • lowered heart rate<\/li>
      • cardiac arrest<\/li>
      • chest pain (not in the heart)<\/li>
      • inflammation of the membranes covering the eyeball and eyelids<\/li>
      • abdominal pain<\/li>
      • joint pain<\/li>
      • temporary respiratory arrest or sudden respiratory arrest<\/li>
      • protein loss in the urine<\/li>
      • nephrotic syndrome: swelling of the legs, general swelling and loss of protein in the urine<\/li>
      • swelling and thickening of the skin at the infusion site in case of leakage of the product outside the blood vessels<\/li><\/ul>\n\n\n\n

        How to store Myozyme<\/h2>\n\n\n\n

        Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n

        Do not use this medicine after the expiry date which is stated on the label after “EXP”. The expiration date is the last day of the specified month.<\/p>\n\n\n\n

        Store in a refrigerator (2 \u00b0 C – 8 \u00b0 C).<\/p>\n\n\n\n

        After dilution, the product should be used immediately. However, chemical and physical in-use stability has been demonstrated for up to 24 hours at 2 to 8 \u00b0 C and when stored in light protection.<\/p>\n\n\n\n

        Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.<\/p>\n\n\n\n

        Contents of the pack and other information<\/h2>\n\n\n\n

        Content declaration<\/h2>\n\n\n\n
        • The active substance is algal glucosidase alfa. One vial contains 50 mg of alglucosidase alfa. After reconstitution, the solution contains 5 mg of alglucosidase alfa \/ ml and, after dilution, the concentration varies between 0.5 mg and 4 mg per ml.<\/li>
        • The other ingredients are
          • Mannitol (E421)<\/li>
          • Sodium hydrogen phosphate monohydrate (E339)<\/li>
          • Sodium dihydrogen phosphate heptahydrate (E339)<\/li>
          • Polysorbate 80 (E433).<\/li><\/ul><\/li><\/ul>\n\n\n\n

            What the medicine looks like and contents of the pack<\/h2>\n\n\n\n

            Myozyme is a powder for concentrate for solution for\u00a0infusion\u00a0in a\u00a0vial\u00a0(50 mg\/vial).\u00a0Each pack contains 1, 10, or 25 vials.\u00a0Not all pack sizes may be marketed.<\/p>\n\n\n\n

            The powder is white to off-white.\u00a0After\u00a0reconstitution, it is clear, colorless to a pale yellow solution, which may contain particles.\u00a0The reconstituted solution must be further diluted.<\/p>\n\n\n\n

            Marketing Authorisation Holder<\/h2>\n\n\n\n

            Genzyme Europe BV, Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands<\/p>\n\n\n\n

            Manufacturer<\/strong>
            Genzyme Ireland Limited, IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland<\/p>\n\n\n\n

            <\/p>\n","protected":false},"excerpt":{"rendered":"

            Myozyme is used to treat adults, children and adolescents of all ages where the diagnosis of Pompe disease is established.<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"cybocfi_hide_featured_image":"","footnotes":""},"categories":[2200,15580],"tags":[18242,18245,18246,18251,18247,18250,18244,18243,18248,18249],"class_list":["post-18530","post","type-post","status-publish","format-standard","hentry","category-medicines","category-m","tag-alglucosidase-alfa","tag-alglucosidase-alfa-side-effects","tag-benefits-of-alglucosidase-alfa","tag-benefits-of-myozyme","tag-myozyme","tag-myozyme-side-effects","tag-what-alglucosidase-alfa-is-used-for","tag-what-is-alglucosidase-alfa","tag-what-is-myozyme","tag-what-myozyme-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/18530","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/comments?post=18530"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/18530\/revisions"}],"predecessor-version":[{"id":18562,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/18530\/revisions\/18562"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=18530"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=18530"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=18530"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}