Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about Miacalcic.

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

The information in this leaflet was last updated on the date listed on the final page.

Some more recent information on the medicine may be available.

You should ensure that you speak to your pharmacist or doctor to obtain the most up to date information on the medicine.

Those updates may contain important information about the medicine and its use of which you should be aware.

All medicines have risks and benefits. Your doctor has weighed the risks of you using Miacalcic against the benefits they expect it will have for you.

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

Keep this leaflet with the medicine. You may need to read it again.

What Miacalcic is used for

Miacalcic contains calcitonin salmon (salcatonin), which is similar to calcitonin, a hormone produced by the body.

• Miacalcic is used to treat Paget's disease when other therapies cannot be used or have proven unsuccessful

Paget's disease is a chronic disorder of the bones of the skeleton. Bone is a living tissue and, just like other parts of the body, it is constantly being renewed. This process is called bone remodelling.

Remodelling involves two types of bone cells - osteoclasts, which break down old bone and osteoblasts, which make new bone. In people with Paget's disease the osteoclasts in some bones are overactive, causing the bone to break down more quickly than usual. The osteoblasts then try to work faster to replace the lost bone. The new bone that is formed may be thicker but weaker than normal, which can cause pain and may lead to fractures (broken bones).

Miacalcic works by slowing down the breakdown of bone by the osteoclasts. This allows bone remodelling to go back to normal and protects the bones from being weakened. Miacalcic may also relieve bone pain.

• Miacalcic is also used to treat hypercalcaemia (high calcium levels in the blood)

It helps to reduce the level of calcium in the blood when it becomes too high.

Ask your doctor if you have any questions about why Miacalcic has been prescribed for you. Your doctor may have prescribed this medicine for another reason.

Miacalcic is only available with a doctor's prescription. It is not addictive.

Miacalcic is not recommended for children except in special cases, since experience with using Miacalcic in this age group is limited.

Before you use Miacalcic

When you must not use it

Do not use Miacalcic if you have an allergy to:

• calcitonin salmon (salcatonin), the active ingredient in Miacalcic
• any of the other ingredients listed at the end of this leaflet

You may get hives or an itchy skin rash, swelling of the face, lips, tongue or throat, wheezing or troubled breathing, fast heart beat, faintness or other symptoms if you use it.

Your doctor may have performed a skin test to check for an allergy before giving you this medicine. See the 'Side Effects' section of this leaflet for more information about allergic reactions.

Do not use Miacalcic if you are pregnant or breast-feeding. There is not enough experience with Miacalcic in pregnant women or nursing mothers to recommend its use. Your doctor can discuss with you the risks and benefits of using this medicine while you are pregnant or breast-feeding.

Do not use Miacalcic if the packaging is torn or shows signs of tampering. In that case, return it to your pharmacist.

Do not use Miacalcic after the use by (expiry) date printed on the pack or ampoule. If you use it after the expiry date has passed, it may not work as well as it should.

Before you start to use it

Tell your doctor if you have any problems with your kidneys. Your doctor may want to prescribe a lower dose of Miacalcic than usual if you have a kidney problem.

Taking other medicines

Tell your doctor if you are taking lithium. Your dosage may need to be adjusted.

Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from a pharmacy, supermarket or health food shop. Other medicines may affect the way Miacalcic works. Your doctor or pharmacist can tell you what to do if you are taking any other medicines.

If you have not told your doctor about any of these things, tell him/her before you use Miacalcic.

How to use Miacalcic

Follow all directions given to you by your doctor and pharmacist carefully. These directions may differ from the information contained in this leaflet.

If you do not understand the instructions on the label, ask your doctor or pharmacist for help.

How it is given

Miacalcic cannot be taken by mouth because it is rapidly broken down in the stomach. Instead it is given as an injection. It can be injected intravenously (into the vein) or intramuscularly (into the muscle of the thigh or buttock). It can also be injected subcutaneously. That means that it is injected into the layer of fat just under the skin.

If you will be giving the subcutaneous injections yourself, your doctor or nurse will teach you how to inject yourself properly.

If you are not sure about anything, ask your doctor or nurse before you start.

How much is given

The dose of Miacalcic depends on the condition being treated.

For Paget's disease: the usual dose is 80 to 100 I.U. (international units) of Miacalcic each day or every second day. The dose is given by intramuscular or subcutaneous injection. The dose of Miacalcic may be adjusted depending on the response to treatment. This medicine may be needed for anywhere from a few months to a few years.

For hypercalcaemia: the usual dose is 5 to 10 I.U. of Miacalcic per kg of body weight per day. It can be given intravenously or by intramuscular or subcutaneous injection.

If you forget to use it

If it is more than 4 hours until your next dose is due, inject the dose as soon as you remember and then go back to injecting it as you would normally.

If it is less than 4 hours until your next dose is due, wait and inject your dose at the usual time.

Do not use a double dose to make up for the one that you missed. It won't do any harm if you miss a dose but some of your symptoms may come back temporarily until you get back on schedule.

If you have trouble remembering when to use your medicine, ask your pharmacist for some hints.

If you use too much (overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at your nearest hospital if you think that an overdose has happened. Do this even if there are no signs of discomfort or poisoning.

While you are using Miacalcic

Things you must do

Keep all of your doctor's appointments so that your progress can be checked. If you have to take Miacalcic for a long time (for example, to treat Paget's disease), your doctor may want you to have X-rays or blood and urine tests from time to time to make sure Miacalcic is working and to prevent unwanted side effects from happening. If you are receiving Miacalcic solution for injection or infusion for a long time, tell your doctor and your doctor would evaluate the benefit against possible risks and advise you. Using Miacalcic for a long time might increase the risk of cancer.

See your doctor if your symptoms reappear. Sometimes after using Miacalcic for a while, your symptoms may reappear (this is called a "rebound" effect). If this happens, your doctor may stop Miacalcic for a short time and then start it again. This helps to restore the good effects of the medicine.

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are having treatment with Miacalcic.

Tell any other doctor, dentist or pharmacist who treats you that you are having treatment with Miacalcic.

Things you must not do

Do not give this medicine to anyone else, even if their symptoms seem to be the same as yours.

Do not use Miacalcic to treat any other complaints unless your doctor tells you to.

Things to be careful of

Be careful driving or operating machinery until you know how Miacalcic affects you. This medicine may cause dizziness in some people. Make sure you know how you react to Miacalcic before you drive a car, operate machinery or do anything else that could be dangerous.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Miacalcic. All medicines can have side effects. Sometimes they are serious, but most of the time they are not. You may need medical treatment if you get some of the side effects.

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.

Tell your doctor if you notice any of the following side effects and they worry you:

• redness, swelling or pain at the site of injection
• nausea or vomiting
• abdominal pain
• a hot flushed face
• dizziness
• frequent passing of urine or passing large amounts of urine
• diarrhoea
• headache
• fever and chills
• pain in the joints
• numbness, tingling or cramps in arms or legs
• itching of the palms of the hands
• unusual taste
• fatigue
• visual disturbances
• trembling

Stop using Miacalcic and tell your doctor immediately or go to Accident and Emergency at your nearest hospital if any of the following happen:

• a severe reaction at the site of injection
• swelling of the face, lips, tongue or throat
• swelling of other parts of the body such as legs or ankles
• tightness in the chest, wheezing or troubled breathing
• hives or an itchy skin rash (can affect entire body)
• fast heartbeat
• fainting

You may be having a serious allergic reaction to Miacalcic and may need urgent medical attention or hospitalisation. Allergic reactions are rare.

Tell your doctor if you notice anything else that is making you feel unwell. Other side effects not listed above may happen in some people.

After using Miacalcic

Storage

• Keep the ampoules in the carton until it is time to use them.
• Keep your ampoules in the refrigerator (about 2°C to 8°C). Do not freeze.

Keep the medicine where children cannot reach it.

Disposal

Throw out any Miacalcic left in the ampoule once the dose has been injected.

Miacalcic does not contain any preservatives.

Dispose of the used ampoules safely.

If your doctor tells you to stop using Miacalcic or you find that it has passed the expiry date or has been left out of the fridge, ask your pharmacist what to do with any medicine you have left over.

Product description

What it looks like

Each Miacalcic pack contains 5 ampoules of calcitonin salmon (salcatonin).

Ingredients

Each 1 mL ampoule of Miacalcic contains either 50 I.U. or 100 I.U. calcitonin salmon (salcatonin) . The ampoule also contains glacial acetic acid, sodium acetate, sodium chloride and water for injections.

Sponsor

Miacalcic is supplied in Australia by:

Chiesi Australia Pty Ltd
Suite 3, 22 Gillman Street,
Hawthorn East, VIC. 3123
Australia
E: [email protected]
W: www.chiesi.com.au

® = Registered Trademark

This leaflet was prepared in May 2022.

Australian Registration Number:

50 I.U./1 mL ampoule: AUST R 13364

100 I.U./1 mL ampoule: AUST R 13363

Published by MIMS January 2023

1 Name of Medicine

Calcitonin salmon (salcatonin).

2 Qualitative and Quantitative Composition

Each 1 mL injection contains 50 or 100 IU calcitonin salmon (salcatonin) (present as polyacetate polyhydrate).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Clear, colourless solution, practically free of visible foreign particles.

4 Clinical Particulars

4.1 Therapeutic Indications

Active Paget's disease in patients who do not respond to alternative treatments or for whom such treatments are not suitable.
Hypercalcaemia.

4.2 Dose and Method of Administration

Note.

Dosage.

Hypercalcaemia.

Paget's disease.

Method of administration.

Elderly.

Hepatic impairment.

Renal impairment.

4.3 Contraindications

Pregnancy and lactation (see Section 4.6 Fertility, Pregnancy and Lactation). Hypersensitivity to calcitonin salmon (salcatonin) or to any of the excipients in the formulation.

4.4 Special Warnings and Precautions for Use

Hypersensitivity reactions.

Malignancies.

Sensitivity testing.

Escape phenomena.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Concomitant use of calcitonin salmon (salcatonin) and lithium may lead to a reduction in plasma concentrations. The dose of lithium may need to be adjusted.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

Miacalcic may cause fatigue, dizziness and visual disturbances (see Section 4.8 Adverse Effects (Undesirable Effects)), which may impair the reactions of the patient. Patients should be warned that these effects may occur, in which case they should not drive or use machines.

4.8 Adverse Effects (Undesirable Effects)

For Miacalcic ampoules no recent frequency estimations based on clinical trials are available. Estimations based on the number of post-marketing reports received lead to frequencies lower than those reported in controlled clinical trials with Miacalcic nasal spray. For events attributed to the systemic administration of calcitonin salmon (salcatonin) therefore the same (higher) frequency categories as used for the nasal spray was also used for Miacalcic ampoules.
Adverse reactions below are listed by MedDRA system organ class. Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first. Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness. In addition, the corresponding frequency category for each adverse drug reaction is based on the following convention (CIOMS III): very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).

Immune system disorders.

Nervous system disorders.

Eye disorders.

Vascular disorders.

Gastrointestinal disorders.

Skin and subcutaneous tissue disorders.

Musculoskeletal and connective tissue disorders.

Renal and urinary disorders.

General disorders and administration site conditions.

Immunological.

Malignancies.

Post-marketing experience.

Central and peripheral nervous system.

Metabolism and nutrition disorders.

Skin and subcutaneous tissue disorders.

Reporting suspected adverse effects.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).
Nausea, vomiting, flushing and dizziness are known to be dose dependent when Miacalcic is administered parenterally. Nausea and vomiting have occurred following administration of Miacalcic as a parenteral overdose, but severe adverse reactions due to overdosage have so far not been reported.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group, ATC code: Regulator of calcium homeostasis, H05BA01.
The secretion and biosynthesis of calcitonin in both animals and man are regulated by the concentration of calcium in plasma. When the calcium concentration is high the amount of the hormone increases.
The pharmacological activity of salmon calcitonin is the same as that of mammalian calcitonin. In man, data on relative potency are sparse, but calcitonin salmon (salcatonin) is thought to be at least 10-40 times as potent by weight as porcine or human calcitonin in producing hypocalcaemia depending on methodology. Presumably due to its greater affinity for receptor binding sites in bone and kidney, and slower rate of metabolism, calcitonin salmon (salcatonin) has a longer duration of action.
Calcitonin inhibits osteoclastic bone resorption, altering both the number and/or resorptive activity of osteoclasts. There is suggestive evidence in animals and man that calcitonin may promote bone and collagen formation via an increase in osteoblastic activity. However, the exact role of calcitonin on osteoblastic activity has not been fully established.
Calcitonin decreases the rate of bone turnover in conditions with an increased rate of bone resorption and formation, such as active Paget's disease, malignant osteolysis and some forms of osteoporosis characterised by a high bone turnover. This can be measured biochemically as a decrease in urine hydroxyproline excretion and a decrease in serum alkaline phosphatase levels.
Calcitonin treatment of Paget's disease may relieve bone pain, lower skin temperature over involved bone, decrease excessive cardiac output, stabilise hearing and allow radiographic and histological regression of bone lesions. Clinical experience demonstrates that calcitonin salmon (salcatonin) possesses analgesic activity. Investigations have shown binding sites specific to calcitonin salmon (salcatonin) in some areas of the central nervous system.
Calcitonin increases the excretion of phosphate, calcium and sodium by decreasing their tubular reabsorption.
Calcitonin is effective in diminishing hypercalcaemia in patients with hyperparathyroidism, vitamin D intoxication and osteolytic bone metastases.
The gastrointestinal effects attributed to calcitonin include the inhibition of gastric acid secretion, stimulation of the intestinal secretion of water and electrolytes, inhibition of pancreatic enzyme secretion and modifications of glucose insulin relationships. Calcitonin probably has no major effects on the intestinal absorption of calcium and does not affect gastrointestinal motility.

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Glacial acetic acid, sodium acetate, sodium chloride, water for injections.

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

Store at 2-8°C. Refrigerate. Do not freeze.

6.5 Nature and Contents of Container

1 mL clear Type 1 glass ampoule with a one-point-cut (OPC) for ease of opening. Packs of 5 ampoules per carton.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes