SUMMARY CMI
TIGECYCLINE JUNO
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 given Tigecycline Juno?
Tigecycline Juno contains the active ingredient tigecycline. It is an antibiotic of the tetracycline class in the glycylcycline subcategory that works by stopping the growth of bacteria that cause infections. Your doctor has prescribed Tigecycline Juno because you have one of the following types of serious infections: infection of the skin, including those with resistant bacteria, or infection in the abdomen. For more information, see Section 1. Why am I given Tigecycline Juno? in the full CMI.
2. What should I know before I am given Tigecycline Juno?
Do not use if you have ever had an allergic reaction to tigecycline or any of the ingredients listed at the end of this leaflet.
Talk to your doctor if you have any other medical conditions, 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 I am given Tigecycline Juno? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with Tigecycline Juno 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 will I be given Tigecycline Juno?
Tigecycline Juno is given through slow infusion “drip” into a vein by your doctor or nurse.
More instructions can be found in Section 4. How will I be given Tigecycline Juno? in the full CMI.
5. What should I know while using Tigecycline Juno?
Things you should do |
|
Driving or using machines |
|
Looking after your medicine |
|
For more information, see Section 5. What should I know while using Tigecycline Juno? in the full CMI.
6. Are there any side effects?
Side effects of this medicine may include nausea; vomiting; diarrhoea; constipation; increased cough; backpain; dizziness; headache; loss of appetite; stomach pain or heartburn; swelling of feet, ankles, lower legs, hand or arms; skin rash and itchiness; low sugar levels in blood; increased tendency to bleed or bruise; yellowing of the skin or eyeballs (called jaundice); injection site reaction (pain, redness, inflammation, swelling); swelling and/or clotting; and redness along a vein which is very tender when touched; abscesses or other infections; abnormal healing; sepsis (rapid heartbeat/fever); inflammation of the pancreas (severe upper stomach pain, often with nausea and vomiting); Stevens-Johnson Syndrome (a skin condition with severe blisters and bleeding in the lips, eyes, mouth, nose and genitals); pneumonia; bleeding following injury taking longer to clot; sudden swelling of the lips, face, throat or tongue (allergic reactions).
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
TIGECYCLINE JUNO
Active ingredient: Tigecycline
Consumer Medicine Information (CMI)
This leaflet provides important information about using Tigecycline Juno. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Tigecycline Juno.
Where to find information in this leaflet:
1. Why am I given Tigecycline Juno?
2. What should I know before I am given Tigecycline Juno?
3. What if I am taking other medicines?
4. How do I use Tigecycline Juno?
5. What should I know while I am given Tigecycline Juno?
6. Are there any side effects?
7. Product details
1. Why am I given Tigecycline Juno?
Tigecycline Juno contains the active ingredient tigecycline. It is an antibiotic of the tetracycline class in the glycylcycline subcategory that works by stopping the growth of bacteria that cause infections.
Your doctor has prescribed Tigecycline Juno because you have one of the following types of serious infections:
Infection of the skin, including those with resistant bacteria
Infection in the abdomen.
Tigecycline Juno will not work against viral infections such as colds or flu.
2. What should I know before I am given Tigecycline Juno?
Warnings
Do not use Tigecycline Juno if:
- you are allergic to tigecycline or any of the ingredients listed at the end of this leaflet.
- Always check the ingredients to make sure you can use this medicine.
Some of the symptoms of an allergic reaction may include rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or troubled breathing.
Check with your doctor if you:
- have previously had an allergic reaction to tetracycline antibiotics.
You may have an increased chance of being allergic to Tigecycline Juno if you are allergic to tetracyclines. - have or have had liver problems.
Depending on the condition of your liver, your doctor may need to reduce your dose to avoid potential side effects.
Your doctor should do blood tests before you start and regularly while you are being treated with Tigecycline Juno
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.
As with many medicines, Tigecycline Juno may harm your developing or breastfeeding baby. This may include permanent staining of the child's teeth.
Use in children
There is no experience with the use of Tigecycline Juno in children under 18 years of age. Tigecycline Juno, like other tetracyclines, may cause enamel loss and staining in developing teeth.
There is no evidence that Tigecycline Juno is addictive.
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 Tigecycline Juno. These include:
- medicines to treat infections that contain ketoconazole or rifampicin
- medicines that contain ciclosporin or tacrolimus
- warfarin, if you are taking warfarin, your doctor or nurse will check your blood clotting time.
- oral contraceptives (birth control pills). Tigecycline Juno may interfere with birth control pills.
Talk to your doctor about the need for an additional method of contraception while receiving Tigecycline Juno.
Your doctor or pharmacist has more information on medicines to be careful with or avoid while being given Tigecycline Juno.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Tigecycline Juno.
4. How will I be given Tigecycline Juno?
How much will be given
The recommended dosage is 100 mg for the first dose, followed by 50 mg every 12 hours.
It is very important that you continue to receive TIGECYCLINE JUNO for as long as your doctor prescribes it.
How is Tigecycline Juno given
Tigecycline Juno is given through slow infusion “drip” into a vein by your doctor or nurse.
Your doctor will decide how many days of treatment you need. How long you receive Tigecycline Juno will depend on how severe your infection is and how quickly you respond to treatment.
If you are given too much Tigecycline Juno
It is unlikely that you will receive an overdose of Tigecycline Juno as it will be administered by a trained nurse or doctor. If you think that you have been given too much Tigecycline Juno, 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 while using Tigecycline Juno?
Things you should do
- If you get severe diarrhoea, tell your doctor or nurse immediately. Do this even if it happens several weeks after treatment with Tigecycline Juno has been stopped.
Diarrhoea may mean that you have a serious condition affecting your bowel. You may need urgent medical care.
- Do not take any medicine for diarrhoea without first checking with your doctor.
- Tell your doctor immediately if you develop severe abdominal pain, nausea and vomiting.
These may be symptoms of inflammation of the pancreas.
- Tell your doctor immediately if you realise that you are pregnant while being given Tigecycline Juno.
If you are about to start any new medicines, tell your doctor and pharmacist that you are being given Tigecycline Juno. Tell all doctors, dentists and pharmacists who are treating you that you are being given Tigecycline Juno.
Things to be careful of
- Tell your doctor if you get thrush (a fungal infection which can affect the mouth and/or vagina) or any other infection while having, or soon after stopping Tigecycline Juno.
Although antibiotics, including Tigecycline Juno, fight certain bacteria, other bacteria and fungi may continue to grow. Your doctor will check you for any possible infections and, if necessary, will give you treatment. - Protect your skin when you are in the sun, especially between 10 am and 3 pm. If outdoors, wear protective clothing and use a 30+ sunscreen.
Tigecycline Juno may cause your skin to be much more sensitive to sunlight than it is normally. Exposure to sunlight may cause a skin rash, itching, redness, or severe sunburn.
Driving or using machines
Be careful driving or operating machinery until you know how Tigecycline Juno affects you. Whilst it is unlikely that you will drive or operate machinery when having Tigecycline Juno, you need to be aware that Tigecycline Juno may cause side effects such as dizziness. This may affect your ability to drive or operate machinery.
Looking after your medicine
- The hospital will store TIGECYCLINE JUNO under the correct conditions.
- TIGECYCLINE JUNO must be kept out of the reach and sight of children. TIGECYCLINE JUNO will be given to you only within the "Exp. Date" date of the product.
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.
Tigecycline Juno is effective against certain serious infections for most people but it may have unwanted side effects in some.
See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.
Less serious side effects
Less serious side effects | What to do |
| Speak to your doctor if you have any of these less serious side effects and they worry you. |
Serious side effects
Serious side effects | What to do |
| Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these 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.
Some of these side effects (for example, abnormal blood test results including low level of protein/platelet in the blood, high levels of liver enzymes, high levels of enzyme found in the salivary glands/ pancreas and increase in blood urea nitrogen) can only be found when your doctor does tests from time to time to check your progress.
Tell your doctor immediately if you notice any of the following side effects, particularly if they occur several weeks after stopping treatment with Tigecycline Juno.
- Severe abdominal cramps or stomach cramps
- Watery and severe diarrhoea, which may also be bloody
- Fever in combination with one or both of the above.
These are serious side effects. You may have a serious condition affecting your bowel. Therefore, you may need urgent medical attention.
Do not take any medicine for this diarrhoea without first checking with your doctor
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
This medicine is only available with a doctor's prescription.
What Tigecycline Juno contains
Active ingredient (main ingredient) |
|
Other ingredients (inactive ingredients) |
|
Do not take this medicine if you are allergic to any of these ingredients.
What Tigecycline Juno looks like
TIGECYCLINE JUNO is an orange to orange-red powder or cake supplied in glass vials. Dissolving the powder in a sterile liquid makes a solution for injection. After mixing, the solution is an orange to orange-red colour.
Tigecycline Juno is supplied as:
TIGECYCLINE JUNO tigecycline 50 mg Powder for injection glass vial (AUST R 275811)
Who distributes Tigecycline Juno
Juno Pharmaceuticals Pty Ltd
15 – 17 Chapel Street,
Cremorne,
VIC 3121
Australia
This leaflet was prepared in September 2024.
Published by MIMS November 2024