INVanz

What is INVanz used for?

INVanz is a prescription medicine that is used to treat or prevent bacterial infections.

Description

INVANZ (Ertapenem for Injection) is a sterile, synthetic, parenteral, 1-β methyl-carbapenem that is structurally related to beta-lactam antibiotics.

Chemically, INVANZ is described as [4R-[3(3S*,5S*),4α,5β,6β(R*)]]-3-[[5-[[(3-carboxyphenyl)amino]carbonyl]-3-pyrrolidinyl]thio]-6-(1-hydroxyethyl)-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid monosodium salt. Its molecular weight is 497.50. The empirical formula is C22H24N3O7SNa, and its structural formula is:

Ertapenem sodium is a white to off-white hygroscopic, weakly crystalline powder. It is soluble in water and 0.9% sodium chloride solution, practically insoluble in ethanol, and insoluble in isopropyl acetate and tetrahydrofuran.

INVANZ is supplied as sterile lyophilized powder for intravenous infusion after reconstitution with appropriate diluent  and transfer to 50 mL 0.9% Sodium Chloride Injection or for intramuscular injection following reconstitution with 1% lidocaine hydrochloride. Each single-dose vial contains 1 gram ertapenem equivalent to 1.046 grams ertapenem sodium. The sodium content is approximately 137 mg (approximately 6.0 mEq).

Each vial of INVANZ contains the following inactive ingredients: 175 mg sodium bicarbonate and sodium hydroxide to adjust pH to 7.5.

Before taking INVanz, tell your doctor:

• If you are allergic to INVanz; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you are taking any of these drugs: Divalproex or valproic acid.
• If you are taking probenecid.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take INVanz with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take INVanz?

• Tell all of your health care providers that you take INVanz. This includes your doctors, nurses, pharmacists, and dentists.
• Have your blood work checked if you are on INVanz for a long time. Talk with your doctor.
• Do not use longer than you have been told. A second infection may happen.
• Severe and sometimes deadly allergic side effects have rarely happened with drugs like this one.
• Do not give INVanz to a child younger than 3 months of age.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is INVanz best taken?

Use INVanz as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into a muscle or as an infusion into a vein over a period of time.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are the side effects of INVanz that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Feeling agitated.
• Feeling confused.
• Feeling very tired or weak.
• Mood changes.
• Seizures.
• Shakiness.
• Trouble controlling body movements.
• Feeling very sleepy.
• Diarrhea is common with antibiotics. Rarely, a severe form called C diff–associated diarrhea (CDAD) may happen. Sometimes, this has led to a deadly bowel problem (colitis). CDAD may happen during or a few months after taking antibiotics. Call your doctor right away if you have stomach pain, cramps, or very loose, watery, or bloody stools. Check with your doctor before treating diarrhea.

What are some other side effects of INVanz?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Upset stomach or throwing up.
• Diarrhea.
• Headache.
• Irritation where INVanz is given.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out INVanz?

• If you need to store INVanz at home, talk with your doctor, nurse, or pharmacist about how to store it.

Label

PRINCIPAL DISPLAY PANEL – 10 SINGLE-DOSE VIALS LABEL

• NDC 0006-3843-71
• 10 Single-dose vials
  1 g
• FOR INSTRUCTIONS ON RECONSTITUTION
  AND DILUTION and USUAL DOSAGE:
  Discard vial with unused portion.
  See accompanying circular.
• Each vial contains 1 gram ertapenem,
  equivalent to 1.046 grams ertapenem sodium.
• INVANZ®
  (ertapenem sodium) IV/IM
• FOR INTRAVENOUS OR
  INTRAMUSCULAR USE
• Rx only
• Inactive ingredients: 175 mg sodium
  bicarbonate and sodium hydroxide to
  adjust pH to 7.5.
• Solutions range from colorless to pale
  yellow. Variations of color within this
  range do not affect the potency of the
  product.
• Do not store lyophilized powder above
  25°C (77°F).
• MERCK
• Manuf. for: Merck Sharp & Dohme LLC
  Rahway, NJ 07065, USA
• By: Fareva Mirabel
  Route de Marsat, Riom, 63200, France
  Formulated in France.

SRC: NLM .