Mycapssa (Page 6 of 6)

INSTRUCTIONS FOR USE MYCAPSSA® [my (as in sky)-cap-sah] (octreotide) delayed-release capsules, for oral use

Read this Instructions for Use before you start taking MYCAPSSA and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. Talk to your healthcare provider or pharmacist if you have any questions about how to use MYCAPSSA.

Important information:

  • Each MYCAPSSA wallet contains twenty-eight 20-mg capsules. The number of wallets required in a 28-day period depends on your prescribed dose.

How to Use the MYCAPSSA Wallet

  • Each MYCAPSSA wallet has a locking mechanism that helps to keep the medicine away from children.
  • Become familiar with using the MYCAPSSA wallet so you will know how to use it the right way.

To open the wallet:

Step 1. With your left thumb, gently press the tip of the release button on the left side of the wallet (see Figure A).

Step 2. While holding the release button, grasp the medicine card at the notch on the right side and pull it out (see Figure A).

Step 3. Unfold the medicine card (see Figure A).

Figure A
(click image for full-size original)

Figure A: How to Open the MYCAPSSA Wallet

How to Remove a Capsule from the MYCAPSSA Wallet

Capsules need to be removed carefully, because if they are cracked or broken they may not be as effective. Follow these instructions to easily remove capsules without damaging them.

  • Place the tip of a thumb at the edge of a capsule’s plastic cavity (see Figure B).
  • Gently push the capsule until it is removed. Collect the removed capsule in your hand.
  • Do not use two thumbs to push a capsule as this could damage it.
  • Do not press the middle of a capsule. This could also damage it.
  • If a capsule is cracked or broken, throw it away (discard it) and remove another capsule.
Figure B
(click image for full-size original)

Figure B: How to Remove a Capsule from the Medicine Card Inside the MYCAPSSA Wallet

This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Approved: 06/2020

PRINCIPAL DISPLAY PANEL — 20 mg Blister Pack

Always take with a glass of water on an empty stomach at least
1 hour before a meal or at least 2 hours after a meal.

Mycapssa®
(octreotide) delayed-release capsules

20 mg*

2

28 Capsules

*Each capsule contains octreotide 20 mg (provided as octreotide acetate). Acetate composition varies. See prescribing information.

PRINCIPAL DISPLAY PANEL -- 20 mg Blister Pack
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 20 mg Blister Pack Dose Pack

NDC 69880-120-28

Mycapssa®
(octreotide) delayed-release capsules

20 mg*

Rx only

*Each capsule contains octreotide 20 mg (provided
as octreotide acetate). Acetate composition varies.
See prescribing information.
Keep out of reach of children.

1
PRESS
& HOLD
HERE

PULL OUT HERE


PRESS


PULL

OPENING AND CLOSING INSTRUCTIONS

  • Use left thumb to push the button gently
  • While holding the button down, pull out the medication card
  • Press out to take capsule(s)
  • Slide medication card back to lock

28 capsules

Always take with a glass of water on an empty stomach at least 1 hour before a meal or at least 2 hours after a meal.

CHIASMA®

PRINCIPAL DISPLAY PANEL -- 20 mg Blister Pack Dose Pack
(click image for full-size original)
MYCAPSSA octreotide capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69880-120
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octreotide (Octreotide) Octreotide 20 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONE K12
sodium caprylate
MAGNESIUM CHLORIDE
polysorbate 80
glyceryl monocaprylate
TRICAPRILIN
GELATIN, UNSPECIFIED
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
TITANIUM DIOXIDE
TRIETHYL CITRATE
SILICON DIOXIDE
SODIUM BICARBONATE
TALC
SODIUM LAURYL SULFATE
SHELLAC
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
AMMONIA
Product Characteristics
Color WHITE (Imprinted black) Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code OT20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69880-120-28 4 BLISTER PACK in 1 DOSE PACK contains a BLISTER PACK
1 7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK This package is contained within the DOSE PACK (69880-120-28)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208232 07/06/2020
Labeler — Chiasma Inc. (024497244)
Establishment
Name Address ID/FEI Operations
Almac Pharma Services Ltd 233170864 LABEL (69880-120), PACK (69880-120)
Establishment
Name Address ID/FEI Operations
Encap Drug Delivery 578075491 ANALYSIS (69880-120), MANUFACTURE (69880-120), PACK (69880-120)
Establishment
Name Address ID/FEI Operations
Lyophilization Services of New England (LSNE) 028180765 MANUFACTURE (69880-120)

Revised: 12/2020 Chiasma Inc.

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