The FDA has approved a supplemental New Drug Application (sNDA) for Linzess (linaclotide; Actavis and Ironwood) to allow the capsule contents to be sprinkled in applesauce or water for adults with swallowing difficulties. Also, the FDA has approved additional instructions for patients with nasogastric or gastric feeding tubes.

The updated labeling states that the Linzess capsule and its contents should not be crushed or chewed. If Linzess capsules cannot be swallowed whole, the capsule can be opened up and administered with applesauce or water.

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For administration in applesauce, entire contents (beads) of the capsule should be sprinkled on 1 teaspoonful of applesauce at room temperature and be consumed immediately. For administration in water, entire contents of the capsule should be sprinkled in approximately 1oz (30mL) of bottled water at room temperature. The mixture should be swirled for at least 10 seconds and then immediately swallowed. Another 1oz of water should be added to any remaining beads in the cup, then swirled for 10 seconds, then swallowed immediately.

The drug, which is coated on the surface of the beads, will dissolve off the beads into the water. The visible beads will not dissolve so it is not necessary to consume all the beads to deliver the complete dose.

For nasogastric or gastric feeding tube administration in water, the beads can be sprinkled into 1oz (30mL) of bottled water at room temperature. After swirling the beads for at least 10 seconds, the mixture can be drawn up to an appropriate syringe and dispensed into the tube. After administration, the nasogastric/gastric tube should be flushed with a minimum of 10mL of water.

After dosing of Linzess in either applesauce or water, the first meal of the day can be consumed 30 minutes later.

Linzess is a guanylate cyclase-C agonist approved to treat adults with irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC).

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