Consumer medicine information

Myocrisin

Sodium aurothiomalate

BRAND INFORMATION

Brand name

Myocrisin Solution for injection

Active ingredient

Sodium aurothiomalate

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Myocrisin.

What is in this leaflet

This leaflet answers some common questions about Myocrisin.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you being given this medicine against the benefits they expect it will have for you.

If you have any concerns about being given this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What Myocrisin is used for

Myocrisin is a type of medicine used to help treat rheumatoid arthritis and Still's disease (a form of arthritis in children).

Myocrisin helps to reduce the inflammation which can occur with arthritis.

Your doctor, however, may prescribe Myocrisin for another purpose.

Ask your doctor or pharmacist if you have any questions about why it has been prescribed for you.

This medicine is only available with a doctor's prescription.

Before you are given it

When you must not be given it

Do not receive Myocrisin if you have:

  • liver disease
  • kidney disease
  • diabetes
  • blood disorders or a history of blood disorders
  • any serious skin disorders
  • are pregnant or plan to become pregnant

Do not receive Myocrisin if you are allergic to it or any of the ingredients listed at the end of this leaflet.

Some symptoms of an allergic reaction include skin rash, itching, shortness of breath or swelling of the face, lips or tongue, which may cause difficulty in swallowing or breathing.

Do not use Myocrisin if the solution has darkened in colour.

Any solution darker than a pale yellow should not be used.

Do not receive it if you are pregnant or intend to become pregnant.

It may affect your developing baby if you are given it during pregnancy.

Do not receive it if you are breastfeeding or planning to breastfeed.

Myocrisin passes into breast milk and there is a possibility your baby may be affected.

Do not receive it after the expiry date (EXP) printed on the pack.

If you receive it after the expiry date has passed, it may not work as well.

Do not receive it if the packaging is damaged or shows signs of tampering.

Before you are given it

Tell your doctor if you have allergies to:

  • any of the ingredients listed at the end of this leaflet
  • any other medicines
  • any other substances, such as foods, preservatives or dyes.

Tell your doctor if you are pregnant or intend to become pregnant.

Like most medicines of this kind, Myocrisin is not recommended to be used during pregnancy.

Tell your doctor if you are breastfeeding or planning to breastfeed.

Myocrisin passes into breast milk and there is a possibility your baby may be affected.

Tell your doctor if you have or have had any medical conditions, especially the following:

  • liver disease
  • kidney disease
  • diabetes
  • blood disorders
  • heart or brain disorders
  • high blood pressure
  • any serious skin disorders

Before you start receiving Myocrisin, and before each treatment you doctor may conduct laboratory tests and examine your skin.

Tell your doctor if you plan to have surgery.

If you have not told your doctor or about any of the above, tell them before you are given Myocrisin.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food store.

Some medicines may interfere with Myocrisin. These include:

  • penicillamine, a medicine for treating rheumatoid conditions and for treating heavy metal poisoning
  • phenylbutazone or oxyphen-butazone, medicine for treating inflammation and fever
  • aspirin
  • angiotensin-converting enzyme inhibitors, a type of medicine for treating heart problems.

These medicines may be affected by Myocrisin, or may affect how well it works. You may need to use different amounts of your medicine, or take different medicines. Your doctor will advise you.

Your doctor or pharmacist has more information on medicines to be careful with or to avoid while being given Myocrisin.

How it is given

How much to be given

Your doctor will decide what dose you will receive. This depends on your condition and other factors, such as your weight.

How it is given

This medicine is given as an injection into the muscle by a doctor or trained nurse. It is likely that you will remain under supervision of your doctor for 30 minutes after you have received it.

How long it will be given

Continue receiving your medicine for as long as your doctor tells you.

The medicine helps control your condition, but it does not cure it.

If you receive too much (overdose)

Your doctor or pharmacist has information on how to recognise and treat an overdose. Ask your doctor or pharmacist if you have any concerns.

While you are being given it

Things you must do

Tell all the doctors, dentists and pharmacists who are treating you that you are being given Myocrisin.

If you are about to be started on any new medicine, tell your doctor and pharmacist that you are being given Myocrisin.

If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are being given this medicine.

If you become pregnant while you are being given this medicine, stop using it and tell your doctor or pharmacist immediately.

Be careful driving or operating machinery until you know how Myocrisin affects you.

Side effects

All medicines have some unwanted side effects. Sometimes they are serious, but most of the time they are not. Your doctor or pharmacist has weighed the risks of using this medicine against the benefits they expect it will have for you.

Do not be alarmed by this list of possible side effects.

You may not experience any of them.

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are being given Myocrisin.

It helps most people with arthritis, but it may have unwanted side effects in a few people.

Tell your doctor immediately if you notice any of the following:

Tell your doctor immediately, or go to Accident and Emergency at your nearest hospital if you notice any of the following:

  • a skin rash or skin problems
  • eye problems or blurred vision
  • metallic taste in the mouth
  • yellowing of the skin and/or eyes
  • mouth ulcers and/or inflammation of the tongue
  • your skin becomes pale, you start to feel tired, you become prone to infections or bruising
  • diarrhoea, abdominal pain and/or nausea and vomiting
  • dizziness or feeling faint

These may be serious side effects of Myocrisin. You may need urgent medical attention. Serious side effects are uncommon.

If any of the following happen, stop receiving this medicine and tell your doctor immediately, or go to Accident and Emergency at your nearest hospital:

  • swelling of the face, lips, mouth or throat, which may cause difficultly in swallowing or breathing
  • hives

These are very serious side effects. If you have them, you may have had a serious allergic reaction to Myocrisin. You may need urgent medical attention or hospitalisation.

These side effects are very rare.

Tell your doctor or pharmacist if you notice anything else that is making you feel unwell.

Other side effects not listed above may occur in some consumers.

Do not be alarmed by this list of possible side effects.

You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

After being given it

If you have any queries about any aspect of your medicine, or any questions regarding the information in this leaflet, discuss them with your doctor or pharmacist.

Storage

Myocrisin should be stored in the pharmacy or in the ward. Keep the medicine in a cool, dry place, protected from light where the temperature stays below 25 °C.

Product description

What it looks like

Myocrisin is a clear solution contained within 1 mL ampoules for injection.

Myocrisin is available in boxes of 10 ampoules

Ingredients

Active Ingredient:

Myocrisin 10mg (2%) - 10mg sodium aurothiomalate per 0.5mL

Myocrisin 20mg (4%) - 20mg sodium aurothiomalate per 0.5mL

Myocrisin 50mg (10%) - 50mg sodium aurothiomalate per 0.5mL

Inactive Ingredients:

  • phenylmercuric nitrate
  • water for injection

Myocrisin does not contain gluten, sucrose, lactose, tartrazine or any other azo dyes.

Manufacturer/Sponsor

Myocrisin is made in Italy.

Myocrisin is supplied in Australia by:
sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113

Myocrisin is supplied in New Zealand by:
sanofi -aventis new zealand limited
Level 8, James and Wells Tower
56 Cawley Street
Ellerslie
Auckland

This leaflet was prepared in September 2007

Australian Register Number(s)
10mg Ampoule: AUST R 27518
20mg Ampoule: AUST R 27519
50mg Ampoule: AUST R 27521

® Registered Trademark

BRAND INFORMATION

Brand name

Myocrisin Solution for injection

Active ingredient

Sodium aurothiomalate

Schedule

S4

 

1 Name of Medicine

Sodium aurothiomalate.

6.7 Physicochemical Properties

Clean bright, almost colourless solution.

Chemical structure.


CAS number.

12244-57-4.

2 Qualitative and Quantitative Composition

Each ampoule of Myocrisin solution for injection contains 10 mg, 20 mg or 50 mg of sodium aurothiomalate and phenylmercuric nitrate and water for injections.

3 Pharmaceutical Form

Solution for injection.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Gold preparations, ATC code: M01CB01.

Mechanism of action.

In rheumatoid arthritis, Myocrisin appears to suppress the disease processes in two ways. Firstly it penetrates into the joint cavity and affects the lysosomal membranes. Secondly, it binds to plasma proteins, including IgG, the rheumatoid factor and the immune complex so that when the lysosomes ingest immune complex the gold is absorbed with it and inactivates lysosomal enzymes within the cell.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

No data available.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

4 Clinical Particulars

4.1 Therapeutic Indications

Adjunctive treatment of rheumatoid arthritis that is not adequately controlled by other anti-inflammatory agents and conservative measures. In chronic, advanced cases of rheumatoid arthritis, gold therapy is less valuable.
Still's disease.

4.3 Contraindications

Hypersensitivity to sodium aurothiomalate or to any of the excipients. Patients with severe renal or hepatic disease, diabetes, marked toxaemia, a history of blood dyscrasias or exfoliative dermatitis, a history of systemic lupus erythematosus.
Use in pregnancy is contraindicated (see Section 4.6 Fertility, Pregnancy and Lactation).

4.4 Special Warnings and Precautions for Use

Myocrisin should be administered with extra caution:
in patients with a history of enterocolitis or pulmonary fibrosis;
in patients with a history of urticaria;
in patients with a history of eczema.
Every candidate for gold therapy should be investigated fully to prevent the administration of gold to those with gross renal or hepatic defects, diabetes, marked toxaemia, a history of blood dyscrasias or dermatitis. Before starting treatment, and again before each injection, the urine should be tested for protein, the skin inspected for rashes, and a full blood count performed, with a numerical platelet count (not an estimation) and the readings plotted. The availability, whenever possible, of the results of blood counts before the next injection is a useful aid in minimising toxic reactions. Minimum values below which gold should not be given until the count has been repeated and there is return to normal values are: total white cells 4,000/mm3, neutrophils 2,000/mm3, platelets 150,000/mm3. It is unwise to continue with gold injections when there is a persistent or otherwise unexplained eosinophilia exceeding 1,000/mm3, as this may indicate an impending toxic reaction. Particular vigilance should be maintained during the period when between 300 to 500 mg of gold has been given because it is at this time that a blood dyscrasia is most likely to occur.
If the full blood count is normal after the cumulative gold dose reaches 500 mg, and provided the full blood count remains normal, full blood counts can be done before every second injection. The presence of proteinuria (including albuminuria), pruritus, or rash, or an eosinophilia are indications of developing toxicity; the dose of Myocrisin should be withheld for one to two weeks until all signs have disappeared, when the treatment may be restarted on a smaller dosage (test dose) followed by a decreased frequency of gold injections.
Myocrisin may be given in the presence of a trace of protein, but if there is 30 mg/100 mL or more, in the absence of urinary infection or other cause it may indicate a developing gold nephropathy and the treatment should be stopped.
Generally, this induces a complete reversal although in some instances the proteinuria may persist for many months.
The complaint of metallic taste, sore throat, glossitis, buccal ulceration and or easy bruising or bleeding demands an immediate blood count, followed, if indicated, by appropriate treatment for agranulocytosis, aplastic anaemia and or thrombocytopenia. All patients receiving the drug should be warned both verbally and in writing to report immediately the appearance of pruritus, metallic taste, sore throat, mouth or tongue, stomatitis, buccal ulceration or the development of bruising or unusual bleeding, purpura, epistaxis, bleeding gums, menorrhagia or diarrhoea.
As gold preparations cause ocular adverse effects, ophthalmological examination is recommended if ocular symptoms occur.
Myocrisin should be used with care in patients with marked hypertension or compromised cerebral or cardiovascular circulation.
As with other gold preparations, reactions which resemble anaphylactoid effects have been reported. These effects and anaphylactoid reactions may occur after any course of therapy within the first 10 minutes following drug administration (see Section 4.2 Dose and Method of Administration). If anaphylactoid effects are observed, treatment with Myocrisin should be discontinued.

Use in the elderly.

Myocrisin should be administered with extra caution in the elderly.

Paediatric use.

No data available.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Gold salts should not be used concomitantly with penicillamine.
Extra caution should be exercised if phenylbutazone or oxyphenbutazone are administered concurrently. Gold administration may exacerbate aspirin induced hepatic dysfunction.
Caution is needed in patients treated concomitantly with sodium aurothiomalate and angiotensin-converting enzyme inhibitors due to an increased risk of severe anaphylactoid reactions in these patients.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category B2)
Female patients receiving Myocrisin should be instructed to avoid pregnancy.
Like other heavy metals, gold may pass the placental barrier and may cause foetal damage; therefore, pregnant patients should not be treated with Myocrisin, but as rheumatoid arthritis usually shows an improvement at this time, the withdrawal of gold is more than justifiable.
The presence of gold has been demonstrated in the milk of lactating mothers and in the serum and red blood cells. Lactating mothers should not breast feed their infants.

4.8 Adverse Effects (Undesirable Effects)

These appear to be associated with individual tolerance, and may be largely avoided by careful titration of dosage. Skin rashes are frequent and commonly benign, but as such reactions may be the forerunners of severe gold toxicity, they must never be treated lightly. Skin complications include pruritus, erythema and transient eczema. Proteinuria is less common and indicates caution, but heavy proteinuria (including albuminuria) is a sign of more serious nephritis such as nephrotic syndrome or glomerulonephritis.
There have been some reports of gold deposits in the lens or cornea of patients treated with gold. These deposits have not led to any eye disorders or any degree of visual impairment, and have cleared within 3-6 months of cessation of therapy.
Haematuria may also develop. The most severe reactions due to gold are agranulocytosis, thrombocytopenia or aplastic anaemia; these occur usually in sensitive patients when a total of about 300 mg has been given. Blood disorders including pancytopenia, leucopenia, neutropenia and eosinophilia have also been reported.
Stomatitis and oral mucous membrane reactions (such as ulcers) have been observed. Reactions of the "vasomotor (nitritoid) type" which may resemble anaphylactoid effects have been reported. Flushing, fainting, dizziness and sweating are most frequently reported. Anaphylactic/Anaphylactoid reactions have also been reported.
Neurological manifestations of gold toxicity including very rare cases of peripheral neuropathy, Guillain-Barré syndrome and encephalopathy have been observed.
Hepatotoxicity with cholestatic jaundice is a complication which may occur early in the course of treatment.
Severe skin reactions including exfoliative dermatitis and dermatitis bullous have been reported.
Irreversible skin pigmentation (chrysiasis) can occur in sun-exposed areas after prolonged treatment with Myocrisin.

Other reactions include.

Gastrointestinal reactions such as nausea, vomiting, anorexia, abdominal cramps, diarrhoea, ulcerative enterocolitis; reactions involving the eye such as iritis, corneal ulcers, gold deposits in ocular tissues; peripheral neuropathy, elevated spinal fluid protein; CNS complications including confusion, hallucinations and seizures; hepatitis; jaundice; gold bronchitis; pulmonary injury manifested by interstitial pneumonitis and fibrosis; alopecia; fever; arthralgia.
Treatment with Myocrisin should be discontinued immediately when toxic reactions occur.
Myocrisin should not be reinstated after severe or idiosyncratic reactions.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration 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 at www.tga.gov.au/reporting-problems (Australia) or https://nzphvc.otago.ac.nz/reporting/ (New Zealand).

4.2 Dose and Method of Administration

Myocrisin should be administered only by intramuscular injection.
Because of the possibility of an anaphylactic reaction, it is recommended that patients be kept under medical observation for a period of 30 minutes after the administration of the drug.
Do not use a darkened solution (more than pale yellow).

Rheumatoid arthritis.

Dosage should be adjusted according to the response of the patient. Recommended initial dosage schedules: injection, at weekly intervals, of 1, 5 and 10 mg to test the patient's tolerance, followed by a 50 mg/week to a total of 1 g, or twenty weekly injections of 50 mg to a total of 1 g. Whatever initial dosage regimen is adopted it is essential to continue therapy on a maintenance basis, usually at the rate of 50 mg/month until a total of about 3 g has been given; alternatively, the treatment is continued indefinitely or maintained for at least two years after remission has been achieved.

Still's disease.

Dosage is proportionate to the body weight of the patient. Myocrisin is given at weekly intervals, initiating treatment with the smallest doses and increasing to the following maxima:

Under 25 kg bodyweight.

10 mg.

25 to 50 kg bodyweight.

20 mg.

Over 50 kg bodyweight.

50 mg.
Therapy should be continued for about six months. If at this time there is no improvement the gold is stopped, but in cases showing improvement, maintenance therapy with fortnightly or monthly injections of the previous dosage should be given for one to five years.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.9 Overdose

The appearance of side effects indicates that the individual is receiving more gold than the system can assimilate. Subsequent dose should be withheld or reduced until the reactions have disappeared and the blood count is normal.
Symptomatic treatment should be initiated in case of overdose.
Major skin lesions and serious blood disorders demand hospital admission. Skin reactions should be treated with systemic and topical antihistamines and corticosteroids. In case of overdose, chelation of gold by antidote treatments may be used. If agranulocytosis, thrombocytopenia or aplastic anaemia is diagnosed, immediate injection of dimercaprol, with corticosteroids, androgens and penicillamine orally, must be given. Fresh blood and/or platelet transfusions should be given with reversed barrier nursing pending recovery of the bone marrow.
For general advice on overdose management, contact the Poisons Information Centre, telephone number 13 11 26 (Australia) or the National Poisons Centre, 0800 POISON or 0800 764 766 (New Zealand).

7 Medicine Schedule (Poisons Standard)

S4.

6 Pharmaceutical Particulars

6.1 List of Excipients

See Section 2 Qualitative and Quantitative Composition.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Protect from light. Store below 25°C. Solutions which have darkened in colour must not be used.

6.5 Nature and Contents of Container

Myocrisin 10 mg/0.5 mL, 20 mg/0.5 mL, 50 mg/0.5 mL glass ampoules are available in packs of 10.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

Summary Table of Changes