Description
Doxecitine and doxribtimine combination is used to treat thymidine kinase 2 deficiency (TK2d) in patients with a symptom onset on or before 12 years of age.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Powder for Solution
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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Kygevvi® in children younger than 12 years of age. Safety and efficacy have been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Kygevvi® in the elderly.
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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
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:
- Kidney disease, moderate or severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
- Liver disease—Use with caution. May make this condition 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. To do so may increase the chance of side effects.
This medicine comes with a patient information leaflet and patient instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions.
Take this medicine with food.
To use:
- When this medicine is prescribed for the first time, you will be provided with the carton of 30 packets and ZX2000 administration kit. Do not open the packets until you are ready to use them.
- Prepare a one-day supply of this medicine each morning. Only use the dosing cup, mixing bottle, and oral syringe provided with your ZX2000 kit. Do not use the dosing cup, mixing bottle, and oral syringe if it appears dirty or damaged. Do not use a household measuring cup or spoon.
- Wash your hands before and after using this medicine.
- Pour the needed amount of room temperature water into the mixing bottle. Do not mix it with any other liquids or foods. Tap the packet on a hard surface to settle the powder to the bottom. Fold and tear or cut along the dotted line. Do not use spilled powder. Throw it away and use a new packet.
- Empty the contents into the mixing bottle with water. Pour only 1 packet at a time until you have reached the prescribed number of packets for your one-day supply.
- Screw the dosing cup tightly onto the mixing bottle. Place one hand at the end of the mixing bottle and the other hand at the end of dosing cup. Gently turn the mixing bottle upside down and back at least 20 times.
- Check the mixture. If you see any powder, keep turning it upside down and back. The solution may be cloudy and have some remaining powder at the bottom or top.
- Before you measure and take or give each dose, slowly turn the mixing bottle upside down and back at least 3 times. Unscrew the dosing cup and place it on a flat surface.
- For doses 50 milliliters (mL) or more: Pour the solution into the dosing cup. Drink or give the entire solution from the cup.
- For doses less than 50 mL: Pour the solution into the dosing cup. Use the oral syringe to draw the prescribed dose. Push the plunger all way down to make sure there is no air. Place the tip of the oral syringe into the dosing cup. Pull the plunger back until it reaches the prescribed dose. Make sure your child is sitting upright when giving this medicine. Place the tip of the syringe into your child's mouth and point the syringe towards the inside of either cheek. Push the plunger all the way down.
- You may also give this medicine through a feeding tube. After giving the medicine, flush the tube with the amount of water recommended by the doctor until no solution is left.
- Clean the mixing bottle, dosing cup, and seal with a clean towel. Put the dry seal back into the dosing cup, with the thin side of the seal facing the groove. Wash the oral syringe with cold water. Do not wash them in the dishwasher.
- Do not save the solution for another day.
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 (powder for solution):
- For thymidine kinase 2 deficiency (TK2d):
- Adults and children 12 years of age and older—Dose is based on body weight and must be determined by your doctor. The starting dose is 260 milligrams (mg) per kilogram (kg) of body weight per day (contains 130 mg of doxecitine and 130 mg of doxribtimine), given 3 times a day about 6 hours apart. Your doctor may adjust the dose as needed.
- Children younger than 12 years of age—Use and dose must be determined by your doctor.
- For thymidine kinase 2 deficiency (TK2d):
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
If you miss a dose of this medicine and it is within 2 hours until your next scheduled dose, skip the missed dose and take your next dose at the normal time.
If you spit out the dose or do not take the full dose of this medicine, do not take another dose. Take your next dose at the next scheduled time.
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.
You may store the mixed solution at room temperature or in the refrigerator. Throw away unused oral liquid 16 hours after preparing this medicine or after taking or giving the 3 doses, whichever comes first.
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 before starting and during treatment with this medicine may be needed to check for unwanted effects.
Check with your doctor right away if you have dark urine, loss of appetite, nausea or vomiting, stomach pain, or yellow eyes or skin. These may be symptoms of serious liver problems.
This medicine may cause stomach or bowel problems. Check with your doctor right away if you have diarrhea or vomiting during treatment with this medicine.
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
- Dark urine
- diarrhea
- loss of appetite
- nausea
- stomach pain, severe
- vomiting
- yellow eyes or skin
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.
DRG-80008535
