Patient information: uses, side effects, how to take - Miplyffa

INSTRUCTIONS FOR USE

MIPLYFFA ^®[mye plye' fah]

(arimoclomol) capsules for oral use

This Instructions for Use contains information on how to take or give MIPLYFFA. Read this Instructions for Use before taking or giving MIPLYFFA and each time you get a refill. There may be new information. This Instructions for Use does not take the place of talking to your or your child's healthcare provider about your or your child's medical condition or treatment.

Important Information You Need to Know Before Taking or Giving MIPLYFFA

Take or give MIPLYFFA capsules exactly as instructed by your healthcare provider.
Your healthcare provider will tell you the number of MIPLYFFA capsules to take or give for the prescribed dose.
MIPLYFFA capsules can be swallowed whole with or without food.
If you or your child have difficulty swallowing capsules, MIPLYFFA capsules can be opened and:
- can be taken or given by mouth (see Step 1 to Step 5) or
- through a feeding tube (see Step 6 to 13).
If you miss a dose of MIPLYFFA, skip the missed dose and take or give the next dose of MIPLYFFA at your regularly scheduled time.

Preparing to take or give MIPLYFFA by mouth if you have difficulty swallowing capsules

Supplies needed to take or give 1 dose of MIPLYFFA:

1 MIPLYFFA capsule,
15 mL of liquid (water or apple juice) or soft food (apple sauce, yogurt, or pudding).
small cup
spoon

Step 1: Add 15 mL of water, apple juice, apple sauce, yogurt, or pudding into a small cup. Adding MIPLYFFA to any other liquids is not recommended.
Step 2: Carefully open 1 MIPLYFFA capsule by twisting the top and bottom of the capsule (see Figure A ). Sprinkle the entire contents of the capsule into the small cup (see Figure B ).	Figure A	Figure B
Step 3: Stir the mixture for 15 seconds with a spoon (see Figure C ). After mixing, some of the capsule contents may remain in the mixture.	Figure C
Step 4: Swallow all of the mixture right away (see Figure D ). Do not save any of the mixture for later use. Throw away the MIPLYFFA mixture if not swallowed right away.	Figure D
Step 5: Throw away the empty MIPLYFFA capsule shells in the household trash.

Preparing to take or give MIPLYFFA through a feeding tube (nasogastric or gastric tube)

Supplies needed to take 1 dose of MIPLYFFA:

1 MIPLYFFA capsule
1 feeding tube syringe (at least 20 mL)
water
small cup
spoon

Step 6: Use the feeding tube syringe to measure 20 mL of water into a small cup (see Figure E ).	Figure E
Step 7: Carefully open 1 MIPLYFFA capsule by twisting the top and bottom of capsule (see Figure F ). Sprinkle the entire contents of the capsule into the small cup (see Figure G ). Do not add the contents of the capsule to any other liquids besides water.	Figure F	Figure G
Step 8: Stir the mixture for 15 seconds with a spoon (see Figure H ). After mixing, some of the capsule contents may remain in the mixture.	Figure H
Step 9: Place the feeding tube syringe in the mixture. Pull up on the feeding tube syringe plunger (indicated with a “P” on the figure) to withdraw the whole mixture into the feeding tube syringe (see Figure I ).	Figure I
Step 10: Attach the feeding tube syringe to the feeding tube. Slowly push the plunger (P) to give or take the mixture right away through the feeding tube (see Figure J ). Do not save any of the mixture for later use. Throw away the MIPLYFFA mixture if not given or taken right away.	Figure J
Step 11: Disconnect the empty feeding tube syringe from the feeding tube. Fill the small cup with water.
Step 12: Fill the syringe with 5 mL of water and slowly push the plunger (P) to flush the feeding tube with water (see Figure K ).	Figure K
Step 13: Throw away the empty MIPLYFFA capsule shells in the household trash.