SUMMARY CMI

Neo-B12^® Injection

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I being treated with Neo-B12 Injection?

Neo-B12 Injection contains the active ingredient hydroxocobalamin. Neo-B12 Injection is a form of vitamin B12. Neo-B12 Injection is used for the prevention and treatment of anaemias associated with vitamin B12 deficiency. It is also used to treat diseases of nerves in the eyes.

For more information, see Section 1. Why am I being treated with Neo-B12 Injection? in the full CMI.

2. What should I know before treatment with Neo-B12 Injection?

Do not use if you have ever had an allergic reaction to hydroxocobalamin, or any of the ingredients listed at the end of the CMI or cobalt.

Talk to your doctor if you have or have had any other medical conditions, such as a disease of the spinal cord or folate-deficient megaloblastic anaemia (a type of anaemia caused by the deficiency of another vitamin called folic acid).

Check with your doctor if you take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before treatment with Neo-B12 Injection? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Neo-B12 Injection and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How is Neo-B12 Injection given?

• Neo-B12 Injection is given as an injection into a muscle. It must only be given by a nurse or doctor.
• Your doctor will decide what dose you will receive and how often you will receive it. This depends on your condition and other factors, such as your weight.

More instructions can be found in Section 4. How is Neo-B12 Injection given? in the full CMI.

5. What should I know during treatment with Neo-B12 Injection?

For more information, see Section 5. What should I know during treatment with Neo-B12 Injection? in the full CMI.

6. Are there any side effects?

Common side effects include: diarrhoea, nausea, headache, vomiting, dizziness, acne, skin rash, pain or redness at the injection site, feeling hot or cold, general feeling of weakness or unwell.

Serious side effects include: signs of an allergic reaction (which may include shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue or other parts of the body, rash, itching or hives on the skin), breathlessness (which may be very severe and usually worsens on lying down due to a build-up of fluid in the lungs), changes in heart rate (fast, slow or irregular), chest tightness or pain, swelling or pain in a body part (due to clots in the blood vessels).

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

Neo-B12^® Injection

Active ingredient(s): hydroxocobalamin (hye-drox-oh-koe-BAL-a-min)

Consumer Medicine Information (CMI)

This leaflet provides important information about using Neo-B12 Injection. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about being treated with Neo-B12 Injection.

Where to find information in this leaflet:

1. Why am I being treated with Neo-B12 Injection?
2. What should I know before treatment with Neo-B12 Injection?
3. What if I am taking other medicines?
4. How is Neo-B12 Injection given?
5. What should I know during treatment with Neo-B12 Injection?
6. Are there any side effects?
7. Product details

1. Why am I being treated with Neo-B12 Injection?

Neo-B12 Injection contains the active ingredient hydroxocobalamin. Neo-B12 Injection is a form of vitamin B12. Neo-B12 Injection is used for the prevention and treatment of anaemias associated with vitamin B12 deficiency. It is also used to treat diseases of nerves in the eyes.

Your doctor may have prescribed it for another reason.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

2. What should I know before treatment with Neo-B12 Injection?

Warnings

Do not use Neo-B12 Injection if:

• you are allergic to hydroxocobalamin, or any of the ingredients listed at the end of this leaflet.
• you are allergic to cobalt.

Symptoms of an allergic reaction may include:

• shortness of breath
• wheezing or difficulty breathing
• swelling of the face, lips, tongue or other parts of the body
• skin rash, itching or hives.

Always check the ingredients to make sure you can use this medicine.

You must not be given hydroxocobalamin to treat megaloblastic anaemia of pregnancy (a type of anaemia usually caused by the deficiency of another vitamin called folic acid).

Check with your doctor if you:

• have or have had any other medical conditions, especially the following:
  - a disease of the spinal cord
  - folate-deficient megaloblastic anaemia (a type of anaemia caused by the deficiency of another vitamin called folic acid)
• take any medicines for any other condition
• have allergies to any other medicines, foods, preservatives or dyes.

If you have not told your doctor about any of the above, tell them before you are given Neo-B12 Injection.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Your doctor can discuss with you the possible risks and benefits involved.

3. What if I am taking other medicines?

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

Some medicines may interfere with Neo-B12 Injection and affect how it works. These include:

• chloramphenicol, a medicine used to treat infections
• the contraceptive pill (birth control pill)
• folic acid.

These medicines may be affected by hydroxocobalamin, or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Neo-B12 Injection.

Your doctor and pharmacist may have more information on medicines to be careful with or avoid while being treated with Neo-B12 Injection.

4. How is Neo-B12 Injection given?

How is it given

• Neo-B12 Injection is given as an injection into a muscle.
• It must only be given by a nurse or doctor.

How much is given

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

If you receive too much (Overdose)

As Neo-B12 Injection is given to you under the supervision of your doctor, it is very unlikely that you will receive too much.

Symptoms of an overdose may include the side effects listed under Section 6. Are there any side effects? but are usually of a more severe nature.

If you experience severe side effects or if you think that you have been given too much Neo-B12 Injection, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know during treatment with Neo-B12 Injection?

Things you should do

• Tell any other doctors, dentists, and pharmacists who treat you that you are being given Neo-B12 Injection.
• If you are to be started on any new medicine, remind your doctor and pharmacist that you are being given Neo-B12 Injection.
• If you become pregnant while you are being treated with Neo-B12 Injection, tell your doctor immediately.
• If you are going to have surgery, tell the surgeon or anaesthetist that you are being given Neo-B12 Injection. It may affect other medicines used during surgery.
• If you are about to have any blood tests, tell your doctor that you are being given Neo-B12 Injection. It may interfere with the results of some tests.
• Keep all of your doctor's appointments so that your progress can be checked. Your doctor may do some tests from time to time to make sure the medicine is working and to prevent any unwanted side effects.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Neo-B12 Injection affects you.

Looking after your medicine

• Neo-B12 Injection is usually stored in the doctor's surgery or clinic, or at the pharmacy.
• If you need to store Neo-B12 Injection, keep it in the original pack until it is time for it to be given.

Store below 25°C. Store in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Do not use this medicine after the expiry date.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

Neo-B12 Injection should not be given to you if the packaging is torn or shows signs of tampering.

If your doctor tells you to stop using Neo-B12 Injection or it is out of date, take any ampoules that are left over to a pharmacy for safe disposal.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Common side effects

Serious side effects

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

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

What Neo-B12 Injection contains

Do not use this medicine if you are allergic to any of these ingredients.

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

What Neo-B12 Injection looks like

Neo-B12 Injection is a clear, dark red solution in a glass ampoule. It is available in packs of 3 ampoules.

• 1000 micrograms/1 mL ampoules x 3 (AUST R 121709)

Who distributes Neo-B12 Injection

Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
www.pfizermedinfo.com.au

This leaflet was prepared in June 2022.

Published by MIMS August 2022

1 Name of Medicine

Hydroxocobalamin chloride (vitamin B₁₂).

2 Qualitative and Quantitative Composition

Each ampoule contains hydroxocobalamin chloride equivalent to hydroxocobalamin 1000 micrograms, sodium chloride 9.0 milligrams and 1 N acetic acid for pH adjustment and Water for Injections. The pH of the solution is approximately 4.6.
Hydroxocobalamin is a dark red, odourless crystalline powder or crystals. It is soluble in water and alcohol, sparingly soluble in methyl alcohol and practically insoluble in acetone, chloroform and ether.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Neo-B12 Injection is a clear, dark red, sterile solution for injection supplied in colourless glass containers (ampoules) of 1 mL.

4 Clinical Particulars

4.1 Therapeutic Indications

Prophylaxis and treatment of pernicious (Addisonian) anaemia and other macrocytic anaemias associated with vitamin B₁₂ deficiency. Treatment of optic neuropathies such as tobacco amblyopia and Leber's optic atrophy.

4.2 Dose and Method of Administration

Dosage.

Initially.

Maintenance.

Initially.

Maintenance.

Initially.

Maintenance.

Method of administration.

4.3 Contraindications

Known sensitivity to hydroxocobalamin or any other ingredient in Neo-B12 Injection. Known sensitivity to cobalt.
Hydroxocobalamin should not be used for the treatment of megaloblastic anaemia of pregnancy (see Section 4.6 Fertility, Pregnancy and Lactation).

4.4 Special Warnings and Precautions for Use

Do not use intravenously.
A sensitivity history should be obtained from the patient prior to administration of vitamin B₁₂. An intradermal test dose is recommended before vitamin B₁₂ is administered to patients who may be sensitive to cobalamins.
Hypokalaemia and cardiac arrest have been reported when megaloblastic anaemia is treated intensively.
Serum potassium is to be carefully monitored during the initial phase of treatment in pernicious anaemia.
Diagnosis of vitamin B₁₂ deficiency should be confirmed by laboratory investigation before institution of hydroxocobalamin (vitamin B₁₂) therapy. Do not use hydroxocobalamin until diagnosis is fully established, as it may mask symptoms of subacute degeneration of the spinal cord, or of the true diagnosis of pernicious anaemia. Folic acid may potentiate the neurological complications of vitamin B₁₂ deficiency, so should not be administered to patients with pernicious anaemia (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Regular blood tests to determine vitamin B₁₂ levels are advisable during treatment.
The platelet count should be monitored during the first weeks of treatment of megaloblastic anaemia because of the possibility of reactive thrombocytosis. Long-term parenteral administration can increase the risk of aluminium toxicity in patients with renal impairment and in preterm infants.
Administration of hydroxocobalamin doses in excess of 10 micrograms daily may improve folate deficient megaloblastic anaemia and obscure the true diagnosis.
The therapeutic response to hydroxocobalamin may be impaired by concurrent infection, uraemia, folic acid or iron deficiency, or by drugs with bone marrow suppressing effects, such as chloramphenicol (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Treatment with hydroxocobalamin may unmask polycythaemia vera, because vitamin B₁₂ deficiency may suppress the symptoms of this condition.
The administration of hydroxocobalamin may impart a pink, red/reddish colour to blood, urine, body fluids and discoloured faeces.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Concurrent administration of chloramphenicol and hydroxocobalamin may impair the therapeutic response to hydroxocobalamin in vitamin B₁₂ deficient patients. The haematological response should be carefully monitored in patients receiving both these drugs.
Hydroxocobalamin may antagonise the toxic effects of cyanide poisoning.
Serum concentrations of hydroxocobalamin may be lowered by oral contraceptives. The clinical relevance of these interactions is not known, but they should be taken into consideration when measuring plasma vitamin B₁₂ concentrations.
Vitamin B₁₂ concentrations in the blood may be reduced following administration of large and continuous doses of folic acid. Folic acid administration may impair the therapeutic response to hydroxocobalamin.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

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.

4.8 Adverse Effects (Undesirable Effects)

Sensitisation to hydroxocobalamin is rare, but may manifest itself as itching exanthema and rarely, anaphylaxis.
Antibodies to hydroxocobalamin transcobalamin II complex may develop during hydroxocobalamin therapy.
Typical adverse events include transitory hypertension, hypokalaemia at the start of the treatment and loss of pigmentation of the skin and mucosa. All these skin reactions tend typically to regress after 1 or 2 days.
Other reported adverse effects include diarrhoea, faeces may have a reddish colour, urine may take on a pink or reddish tinge, nausea, vomiting, headache, dizziness, peripheral vascular thrombosis, chest pain/ discomfort, cardiac arrest, injection site reactions, allergic reactions, generalised itching, redding of the skin, bronchospasm, dyspnoea, sensation of heat and cold, malaise, urticaria or a feeling of swelling of the whole body, angioedema, oropharyngeal oedema, cardiocirculatory collapse, eczematous skin lesions, acne and folliculitis.
Exceptionally anaphylactic shock has been reported.
Pulmonary oedema and congestive heart failure have been reported during early vitamin B₁₂ treatment, possibly as a result of an increase in blood volume induced by the drug.
Polycythaemia vera may occur (see Section 4.4 Special Warnings and Precautions for Use).
Arrhythmias secondary to hypokalaemia have appeared at the beginning of parenteral treatment with hydroxocobalamin.

Reporting suspected adverse effects.

4.9 Overdose

No data available.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Hydroxocobalamin produces higher and more prolonged serum levels of vitamin B₁₂ than cyanocobalamin when given by intramuscular injection in the same dosage. Hydroxocobalamin disperses more slowly from the site of injection than cyanocobalamin, is more strongly bound to plasma proteins and accumulates in the liver to a greater extent.
Hydroxocobalamin is excreted in the bile and urine, but more slowly than cyanocobalamin. Hydroxocobalamin combines with cyanide and thus acts as a cyanide antagonist in vivo resulting in the formation of cyanocobalamin.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Acetic acid, 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

Neo-B12 Injection should be stored below 25°C.

6.5 Nature and Contents of Container

Type I clear glass ampoules containing 1 mg/mL (1,000 micrograms/mL).
3 x 1 mL ampoules.

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)

Not Scheduled.

Summary Table of Changes