CONSTELLA 145 MCG

What is CONSTELLA?

CONSTELLA 145 MCG contains LINACLOTIDE : 145 MCG. It is listed in the Health Canada Drug Product Database under DIN 02417162, held by ABBVIE CORPORATION, supplied as CAPSULE for ORAL administration. Health Canada currently lists it as marketed, status dated 11-Dec-2023. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is CONSTELLA used for?

CONSTELLA (linaclotide capsules) is indicated for the treatment of: • irritable bowel syndrome with constipation (IBS-C) in adults. • chronic idiopathic constipation (CIC) in adults. • functional constipation (FC) in pediatric patients 6 to 17 years of age.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

Product details and regulatory record

How is it administered?

CONSTELLA capsules should be taken orally once daily on an empty stomach, at least 30 minutes before a meal. The capsules should be swallowed whole and should not be chewed. For patients who are unable to swallow the capsule whole, CONSTELLA capsules can be opened and administered orally in applesauce or with water or administered with water via a nasogastric or gastric tube. Sprinkling of CONSTELLA beads on other soft foods or in other liquids has not been tested. For administration in applesauce: • Place one teaspoonful of applesauce at room temperature into a clean container. • Open the capsule. • Sprinkle entire contents (beads) on applesauce. • Consume the contents immediately. Do not chew the beads. Do not store the applesauce and beads for later use. For administration in water: • Pour approximately 30 mL of bottled water at room temperature into a clean cup. • Open the capsule. • Sprinkle entire contents (beads) into the water. • Gently swirl beads and water for at least 20 seconds. • Swallow the mixture of beads and water immediately. • Add another 30 mL of water to any beads remaining in the cup, swirl for 20 seconds and swallow immediately. • Do not store the bead-water mixture for future use. For nasogastric or gastric feeding tube administration in water: • Open the capsule and empty the beads into a clean container with 30 mL of room temperature bottled water. • Mix by gently swirling beads for at least 20 seconds. • Draw up the bead-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. • Add another 30 mL of water to any beads remaining in the container and repeat the process. • After administering the bead-water mixture, flush the nasogastric/gastric tube with a minimum of 10 mL of water. • Use the mixture of beads and water immediately. Do not store for future use. Usual dose: IBS-C: Take 290 mcg orally once a day, at least 30 minutes before a meal. CIC: Take 145 mcg orally, once a day, at least 30 minutes before a meal. Your doctor may prescribe a dose of 72 mcg instead depending on your response. FC: Take 72 mcg orally, once a day, at least 30 minutes before a meal.

Included because it drives pack selection and wastage. Consult the monograph.

How is it stored and handled?

Store at room temperature (15 to 25°C). Keep CONSTELLA 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.

How is it supplied?

CONSTELLA contains linaclotide-coated beads in hard gelatin capsules. CONSTELLA is available as 72, 145 or 290 mcg capsules for oral administration. • 72 mcg Capsules: Each 72 mcg white to off-white, opaque, hard, gelatin capsule is imprinted with grey imprint "FL 72". Available in bottles of 30 capsules. • 145 mcg Capsules: Each 145 mcg white to off-white, opaque, hard, gelatin capsule is imprinted with a grey imprint “FL 145.” Available in bottles of 30 capsules. • 290 mcg Capsules: Each 290 mcg white to off-white, opaque, hard, gelatin capsule is imprinted with a grey imprint “FL 290.” Available in bottles of 30 capsules.

Contraindications

CONSTELLA is contraindicated in: • pediatric patients under 6 years of age due to the risk of serious dehydration. • patients who are hypersensitive to linaclotide or to any ingredient in the formulation or component of the container. • patients with known or suspected mechanical gastrointestinal obstruction.

Warnings and precautions

CONSTELLA is contraindicated in children less than 6 years of age. In nonclinical studies in neonatal mice, administration of a single, clinically relevant oral dose of linaclotide caused deaths due to dehydration. Patients on treatment who experience severe diarrhea should stop CONSTELLA and contact their physician. In post-marketing experience, severe diarrhea associated with dizziness, syncope, hypotension and electrolyte abnormalities (hypokalemia and hyponatremia) requiring hospitalization or intravenous fluid administration have been reported in patients treated with CONSTELLA.

What can be used instead?

Other Canadian products sharing ATC code A06AX04 LINACLOTIDE. 3 of 3 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.

Who else supplies LINACLOTIDE worldwide?

Nexara tracks national medicine registries and published price lists across multiple markets. LINACLOTIDE appears in 6 registered pack listings across 4 markets, published on 3 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.

Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.