Description
Givinostat is used to treat Duchenne muscular dystrophy (DMD). DMD is a rare, inherited muscle disease that is caused by the absence of a protein called dystrophin, which helps keep muscle cells intact.
This medicine is only available with your doctor's prescription.
This product is available in the following dosage forms:
- Suspension
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of givinostat in children younger than 6 years of age. Safety and efficacy have not been established.
Geriatric
DMD is a disease of children and young adults. No information is available on the relationship of age to the effects of givinostat in geriatric patients.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Bepridil
- Cisapride
- Dronedarone
- Mesoridazine
- Pimozide
- Piperaquine
- Saquinavir
- Sparfloxacin
- Terfenadine
- Thioridazine
- Ziprasidone
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abemaciclib
- Acalabrutinib
- Adagrasib
- Alfentanil
- Alfuzosin
- Amiodarone
- Amisulpride
- Amitriptyline
- Anagrelide
- Apomorphine
- Aripiprazole
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Asenapine
- Astemizole
- Atazanavir
- Azithromycin
- Bedaquiline
- Bosutinib
- Buprenorphine
- Buserelin
- Ceritinib
- Chloroquine
- Chlorpromazine
- Ciprofloxacin
- Citalopram
- Clarithromycin
- Clofazimine
- Clomipramine
- Clozapine
- Cobimetinib
- Conivaptan
- Crizotinib
- Cyclobenzaprine
- Cyclosporine
- Dabrafenib
- Dasatinib
- Degarelix
- Delamanid
- Desipramine
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Bleeding problems or
- Heart rhythm problems—Use with caution. May make these conditions worse.
Proper Use
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
This medicine comes with a Medication Guide and patient instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions.
Take this medicine with food. Do not mix this medicine with water or other liquids.
To use the oral liquid:
- Shake the bottle well for at least 30 seconds by continuously turning it up and down. Stop when the oral liquid is mixed well and looks the same throughout.
- Open the bottle by pressing down on the cap and turn the cap to the left (counter-clockwise).
- If you are using the medicine for the first time, take the provided oral syringe and firmly insert the tip of the oral syringe into the bottle adapter opening. If it is not the first time, take the oral syringe and push the plunger all the way down (to remove the air) and firmly insert the tip of the oral syringe into the bottle adapter opening.
- Hold the syringe in place and turn the bottle upside down. Slowly pull the plunger down to pull out a small amount of the oral liquid. Then push the plunger all the way up to remove any air bubbles.
- Slowly pull the plunger down until you reach the prescribed dose. While keeping the plunger in the same position, turn the bottle upright and place it on a flat surface. Remove the oral syringe by gently twisting or pulling it out from the bottle adapter opening. Do not hold the plunger because it may come out.
- Place the tip of the oral syringe against the inside of the cheek and slowly push the plunger all the way down until there is no medicine left in the syringe.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (suspension):
- For Duchenne muscular dystrophy (DMD):
- Adults and children 6 years of age and older—Dose is based on body weight and must be determined by your doctor. Your doctor may adjust your dose as needed and tolerated.
- Weighing 60 kilograms (kg) or more—53.2 milligrams (mg) or 6 milliliters (mL) 2 times a day.
- Weighing 40 kg to less than 60 kg—44.3 mg or 5 mL 2 times a day.
- Weighing 20 kg to less than 40 kg—31 mg or 3.5 mL 2 times a day.
- Weighing 10 kg to less than 20 kg—22.2 mg or 2.5 mL 2 times a day.
- Children younger than 6 years of age—Use and dose must be determined by your doctor.
- Adults and children 6 years of age and older—Dose is based on body weight and must be determined by your doctor. Your doctor may adjust your dose as needed and tolerated.
- For Duchenne muscular dystrophy (DMD):
Missed Dose
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Throw away any unused liquid after 60 days of opening the bottle.
Precautions
It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Givinostat will lower the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers. Call your doctor right away if you have a fever, chills, or any signs or symptoms of an infection.
This medicine may increase the amount of fat (triglycerides) in your blood. Talk to your doctor if you have questions.
This medicine may cause stomach or bowel problems. Check with your doctor right away if you have diarrhea, nausea, stomach pain, or vomiting.
This medicine may cause heart rhythm problems (eg, QT prolongation). Check with your doctor right away if you have dizziness, lightheadedness, fainting, or fast or irregular heartbeat.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Black, tarry stools
- bleeding gums
- blood in the urine or stools
- diarrhea
- difficulty in moving
- joint pain or swelling
- muscle aches and pains
- nausea
- pinpoint red spots on the skin
- stomach pain
- unusual bleeding or bruising
- vomiting
Less common
- Constipation
- depressed mood
- dry skin and hair
- feeling cold
- hair loss
- hoarseness or husky voice
- muscle cramps and stiffness
- slowed heartbeat
- unusual tiredness or weakness
- weight gain
Incidence not known
- Chills
- cough
- dizziness, lightheadedness, or fainting
- fast or irregular heartbeat
- fever
- lower back or side pain
- painful or difficult urination
- pale skin
- sore throat
- ulcers, sores, or white spots in the mouth
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Decreased appetite
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
CON-XXXXXXXX
