LINZESS Capsule, gelatin coated Ref.[49660] Active ingredients: Linaclotide

2.1 Recommended Dosage

Irritable Bowel Syndrome with Constipation (IBS-C)

The recommended dosage of LINZESS is 290 mcg orally once daily.

Chronic Idiopathic Constipation (CIC)

The recommended dosage of LINZESS is 145 mcg orally once daily. A dosage of 72 mcg once daily may be used based on individual presentation or tolerability.

2.2 Preparation and Administration Instructions

• Take LINZESS on an empty stomach, at least 30 minutes prior to the first meal of the day.
• If a dose is missed, skip the missed dose and take the next dose at the regular time. Do not take 2 doses at the same time.
• Do not crush or chew LINZESS capsule or capsule contents.
• Swallow LINZESS capsule whole.
• For adult patients with swallowing difficulties, LINZESS capsules can be opened and administered orally in either applesauce or with water or administered with water via a nasogastric or gastrostomy tube. Sprinkling of LINZESS beads on other soft foods or in other liquids has not been tested.

Oral Administration in Applesauce

1. Place one teaspoonful of room-temperature applesauce into a clean container.
2. Open the capsule.
3. Sprinkle the entire contents (beads) on applesauce.
4. Consume the entire contents immediately. Do not chew the beads. Do not store the bead-applesauce mixture for later use.

Oral Administration in Water

1. Pour approximately 30 mL of room-temperature bottled water into a clean cup.
2. Open the capsule.
3. Sprinkle the entire contents (beads) into the water.
4. Gently swirl beads and water for at least 20 seconds.
5. Swallow the entire mixture of beads and water immediately.
6. Add another 30 mL of water to any beads remaining in cup, swirl for 20 seconds, and swallow immediately.
7. Do not store the bead-water mixture for later use.

Note: The drug is coated on the surface of the beads and will dissolve off the beads into the water. The beads will remain visible and will not dissolve. Therefore, it is not necessary to consume all the beads to deliver the complete dose.

Administration with Water via a Nasogastric or Gastrostomy Tube

1. Open the capsule and empty the beads into a clean container with 30 mL of room-temperature bottled water.
2. Mix by gently swirling beads for at least 20 seconds.
3. Draw-up the beads and water mixture into an appropriately sized catheter-tipped syringe and apply rapid and steady pressure (10 mL/10 seconds) to dispense the syringe contents into the tube.
4. Add another 30 mL of water to any beads remaining in the container and repeat the process.
5. After administering the bead-water mixture, flush nasogastric/gastrostomy tube with a minimum of 10 mL of water.

Note: It is not necessary to flush all the beads through to deliver the complete dose.

Single LINZESS doses of 2897 mcg were administered to 22 healthy subjects; the safety profile in these subjects was consistent with that in the overall LINZESS-treated population, with diarrhea being the most commonly reported adverse reaction.

Store at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].

Keep LINZESS in the original container. Do not subdivide or repackage. Protect from moisture. Do not remove desiccant from the container. Keep bottles tightly closed in a dry place.