Cubact 500 mg Solution

CUBACT is an antibacterial medicine. The active substance, daptomycin, belongs to a group of medicines called antibiotics. It works by stopping the growth of certain bacteria, thereby causing the death of the bacterial cells. CUBACT may be used in adults to treat certain complicated bacterial infections of the skin and the tissues below the skin. It may also be used to treat certain infections of the blood.

CUBACT should not be administered to you, if you:

• are hypersensitive (allergic) to daptomycin or any of the other ingredients of CUBACT;
• have pneumonia (infection of the lungs);
• are below 18 years of age.

Warnings and precautions

Tell your doctor or healthcare provider before being given the injection: Special care should be taken with CUBACT:

• if you have, or have previously had, kidney problems (your doctor may need to adapt your dose);
• what other medicines you are taking. Some medicines may also cause muscle pain and weakness (see Other medicines with CUBACT and section 4).

Serious side effects may occur in some people when treated with CUBACT. See section 4 for possible side effects that require immediate attention. If you have any of the following symptoms, tell your doctor immediately:

• Severe allergic reactions causing difficulty in swallowing or breathing and/or severe skin reactions (blistering, peeling, hives) have been reported. Tell your doctor immediately if you have these reactions (see section 4).
• Severe, persistent diarrhoea (loose bowels), with blood or mucous in the stools and abdominal pain and cramps have been reported. These symptoms may be due to a side effect known as pseudomembranous colitis (C. difficile colitis). This is a condition where the colon is inflamed due to an overgrowth of the bacterium Clostridium difficile. If not treated immediately, it may be life-threatening.
• Tender or aching muscles or muscle weakness, which may be severe and could be due to rhabdomyolysis. Rhabdomyolysis is a condition that occurs due to the breakdown of muscle tissue, thereby releasing myoglobin into the bloodstream. If you have too much myoglobin in your blood, it can cause kidney damage.
• Unusual tingling or numbness of the hands or feet, loss of feeling or difficulties with movements (peripheral neuropathy).
• New or worsening cough, fever, difficulty breathing and sweating at night (eosinophilic pneumonia). Your doctor will check the condition of your lungs and decide whether you should continue CUBACT treatment.

Your doctor will perform blood tests to monitor the health of your muscles both before you start treatment and frequently during treatment with CUBACT. Daptomycin may interfere with laboratory tests that measure how well your blood is clotting. The results can suggest poor blood clotting even if there is no problem. It is therefore important that your doctor considers that you are receiving CUBACT. Please inform the laboratory staff that you are on treatment with CUBACT.

Children and adolescents

Do not give CUBACT to children and adolescents as safety and efficacy have not been established.

Use in elderly

People over the age of 65 can be given the same dose as other adults, provided their kidneys are working well.

Do not share medicines prescribed for you with any other person. You will not be expected to give yourself CUBACT. It will be given to you by a person who is qualified to do so. CUBACT is not intended for children younger than 18 years. CUBACT is dissolved in a sodium chloride intravenous solution for injection. This solution is then infused (dripped) into a large vein. The infusion will last about 30 minutes. It is usually given once daily for up to 14 days.

Your doctor will decide on the dose to use and the duration of the treatment. This will depend on your condition and the type of infection. The dose will depend on how much you weigh, and the type of infection being treated. The usual dose for adults is 4 mg for every kilogram (kg) of body weight once daily for skin infections, or 6 mg for every kg of body weight once daily for a heart infection or a blood infection associated with skin or heart infection. The same dose is recommended in the elderly, provided their kidneys are working well.

If your kidneys do not work well, you may receive CUBACT less often, e.g. once every other day. If you are receiving dialysis, and your next dose of CUBACT is due on a dialysis day, you will usually be given CUBACT after the dialysis session.

If you have the impression that the effect of CUBACT is too strong or too weak, tell your doctor or pharmacist.

If you receive more CUBACT than you should Since a healthcare provider will administer CUBACT, he/ she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If you forget to use CUBACT Since a healthcare provider will administer CUBACT, it is unlikely that the dose will be missed.

If you stop using CUBACT Since a healthcare provider will administer CUBACT, it is unlikely that treatment will be stopped too soon.

CUBACT can have side effects. Not all side effects reported for CUBACT are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving CUBACT, please consult your doctor, pharmacist or other healthcare provider for advice.

If any of the following happens, tell your doctor or healthcare professional immediately:

• Severe allergic reactions: wheezing, difficulty breathing, swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing; or rashes, hives, red skin with fever.
• Yellowing of the eyes and skin, also called jaundice.
• Any unusual tingling or numbness of the hands or feet, loss of feeling or difficulties with movements (peripheral neuropathy). If this happens, your doctor will decide whether you should continue the treatment.
• Antibiotic-associated inflammation of the bowel, including pseudomembranous colitis (severe or persistent watery diarrhoea containing blood or mucous, together with abdominal pain or fever).
• New or worsening fever, cough or difficulty breathing.
• Swelling and problems to urinate, or to produce urine (renal insufficiency or renal failure).
• Skipped heartbeat, heart palpitations or fluttering or jumping of your heart, cardiac arrest. These are all very serious side effects. If you have them, you may have had a serious reaction to CUBACT. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• Urinary tract infection (a strong, persistent urge to urinate, with a burning sensation when urinating)
• Yeast and fungal infections such as thrush
• Anaemia (symptoms may be fatigue and a pale skin)
• Anxiety and difficulty in sleeping
• Dizziness and headache
• High blood pressure or low blood pressure (your blood pressure will be controlled while you are in the hospital)
• Nausea (feeling sick), vomiting (being sick), abdominal pains, flatulence, constipation, bloating, diarrhoea (loose bowels)
• Blood tests may show impaired liver function
• Itching skin, skin rashes
• Pain in the arms and legs, increased serum creatine phosphokinase (CPK test, to determine if tissues are damaged).

Less frequent side effects:

• Blood disorders with high levels of eosinophils (certain white blood cells) and overproduction of platelets in the blood
• Prolonged blood clotting time
• Disease of the lymph nodes (enlargement of lymph nodes, the bean-shaped glands found in the neck, armpits, chest, groin, and abdomen)
• Reactions at the injection site (including a quick heartbeat, fever, weakness, shivers, flushing, feeling faint), tiredness, metallic taste in mouth
• Loss of appetite
• High blood sugar
• Electrolyte imbalance
• Taste disorder
• Tremor
• Tingling or pricking (‘pins and needles’) of the hands or feet
• Vertigo (feels like a spinning or swaying movement)
• An abnormally rapid or irregular heart rate
• Flushes
• Indigestion
• Inflammation of the tongue
• Hallucinations (seeing and hearing things that do not exist)
• Weak muscles, muscle pain, joint pain
• Fatigue
• Pain at injection site
• Protein in the urine (seen with laboratory test)
• Swelling, weakness, chest pain.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of CUBACT.

Store all medicines out of reach of children. Store in a refrigerator (2 - 8 °C). Do not freeze. Do not use this medicine after the expiry date which is stated on the carton and label after EXP.

After reconstitution: Chemical and physical in-use stability of the reconstituted solution in the vial has been demonstrated as up to 12 hours at 25 °C and up to 48 hours at 2 - 8 °C.

After dilution: Chemical and physical stability of the diluted solution in infusion bags is established as up to 12 hours at 25 °C or up to 24 hours at 2 - 8 °C. For the 30-minute intravenous infusion, the combined storage time (reconstituted solution in vial and diluted solution in infusion bag) at 25 °C should not exceed 12 hours (or 24 hours at 2 - 8 °C). From a microbiological point of view the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 - 8 °C.

Do not use CUBACT if you notice any change in the aspect of the product (signs of humidity or presence of particles with a different colour in the powder, or presence of particles, turbidity or precipitate when the solution is reconstituted).

Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).