Pronunciation:

ter-li-PRES-in

Brand Names:

• Terlivaz

Dosage Forms:

• Powder for Solution

Warnings:

Warning: Serious Or Fatal Respiratory FailureTerlipressin may cause serious or fatal respiratory failure. Patients with volume overload or with acute-on-chronic liver failure (ACLF) Grade 3 are at increased risk. Assess oxygenation saturation (eg, SpO2) before initiating terlipressin.Do not initiate terlipressin in patients experiencing hypoxia (eg, SpO2 less than 90%) until oxygenation levels improve. Monitor patients for hypoxia using continuous pulse oximetry during treatment and discontinue terlipressin if SpO2 decreases below 90% .

Classifications:

Therapeutic—

Endocrine-Metabolic Agent

Pharmacologic—

Vasopressin (class)

Uses of This Medicine:

Terlipressin injection is used to improve kidney function in patients with hepatorenal syndrome (kidney problem that occurs in patients with severe liver disease) with rapid change in kidney function.

This medicine is to be given only by or under the immediate supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of terlipressin injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of terlipressin injection in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Heart attack or stroke, history of or
• Heart or blood vessel disease (eg, cardiac, peripheral, or mesenteric ischemia), or history of or
• Hypoxia (low oxygen in the blood) or
• Lung or breathing problems, worsening of—Should not be used in patients with these conditions.

• Liver transplant—This medicine may make you ineligible for liver transplant because of its side effects (eg, respiratory failure, ischemia). Talk to your doctor if you have concerns.

Proper Use of This Medicine:

A doctor or other trained health professional will give you this medicine in a hospital. It is given through a needle placed in a vein. This medicine must be given slowly, so your IV tube will need to stay in place for at least 2 minutes every 6 hours.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests are needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine may cause serious lung problem. Check with your doctor right away if you have blue lips, fingernails, or skin, difficult or trouble breathing, or irregular, fast or slow, or shallow breathing.

This medicine may cause brain or heart problems (eg, cardiac ischemia, cerebrovascular ischemia, peripheral ischemia, or mesenteric ischemia). Check with your doctor right away if you have chest pain or discomfort, confusion, constipation, diarrhea, headache, itching skin, numbness and tingling of the face, fingers, or toes, pain in the arms, legs, or lower back, especially pain in the calves and/or heels upon exertion, pain or discomfort in the arms, jaw, back or neck, pale, bluish-colored, or cold hands or feet, stomach pain, usually after eating a meal, sweating, nausea and vomiting, or weak or absent pulses in the legs.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Blue lips, fingernails, or skin

chest pain or discomfort

chills

confusion

decrease in amount of urine

difficult or trouble breathing

fast heartbeat

fever

irregular, fast or slow, or shallow breathing

lightheadedness, dizziness or fainting

slow or irregular heartbeat

swelling of the fingers, hands, feet, or lower legs

unusual tiredness

weight gain

Less common

Constipation

diarrhea

headache

itching skin

nausea

numbness and tingling of the face, fingers, or toes

pain in the arms, legs, or lower back, especially pain in the calves or heels upon exertion

pain or discomfort in the arms, jaw, back, or neck

pale, bluish-colored, or cold hands or feet

severe numbness, especially on one side of the face or body

stomach pain, usually after eating a meal

sweating

vomiting

weak or absent pulses in the legs

Incidence not known

Blue-green to black skin discoloration

coma

decreased urine output

increased thirst

muscle pain or cramps

pain, redness, or sloughing of the skin at the place of injection

seizures

sores on the skin, especially on the thighs, breasts, penis, or buttocks

swelling of the face, ankles, or hands

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.