Doxecitine; Doxribtimine Powder for Solution

What is this medication?

DOXECITINE; DOXRIBTIMINE (DOX e SYE teen; dox RIB ti meen) treats thymidine kinase 2 (TK2) deficiency, a genetic condition that causes muscle weakness. It works by giving your body extra building blocks to help your cells produce more energy. This can improve symptoms, such as muscle strength.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Liver disease
• An unusual or allergic reaction to doxecitine, doxribtimine, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth. Take it as directed on the prescription label. Take it with food. Keep taking it unless your care team tells you to stop.

To mix a 1-day supply of medication: Measure the prescribed amount of room temperature water. Pour the water into the mixing bottle. Count out the number of packets you need for the day. Empty the contents of the packet(s) into the mixing bottle. Empty one packet at a time. Put the dosing cup on the mixing bottle. Gently turn the bottle upside down and back at least 20 times to mix. Mix until the powder dissolves. The liquid may look cloudy.

Before each dose: Gently turn the bottle upside down and back at least 3 times. Measure your dose from the mixing bottle using the oral syringe or dosing cup. Take your dose right away with food.

After the first and second dose of the day: Clean the oral syringe and dosing cup with cold water. Let them dry. Put the dry dosing cup back on the mixing bottle. Store the mixing bottle at room temperature or in the refrigerator until it is time for your next dose.

After the third dose of the day: Get rid of any remaining solution. Clean the mixing bottle and dosing cup by hand with soap and warm water. Clean the syringe by hand with cold water. Let them dry.

This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions.

Talk to your care team about the use of this medication in children. While it may be prescribed for children for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is within 2 hours of your next dose, skip the missed dose. Take your next dose at the normal time. Do not take double or extra doses.

What may interact with this medication?

Interactions have not been studied.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Severe or prolonged vomiting or diarrhea

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Diarrhea
• Stomach pain
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Packets: Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.

Mixed solution: Store at room temperature or in a refrigerator. Get rid of any unused solution 16 hours after mixing or after taking the 3 daily doses, whichever comes first.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, pour the medication out of the container. Mix it with cat litter, dirt, coffee grounds, or another unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.