DOTAREM Injection is a clear, colorless to yellow solution containing 0.5 mmol/mL of gadoterate meglumine.
- DOTAREM Injection Pharmacy Bulk Package is supplied in 100 mL vials containing 100 mL of solution.
Each Pharmacy Bulk Package vial is closed with a rubber stopper and sealed with an aluminum cap and the contents are sterile. DOTAREM Pharmacy Bulk Package is packaged in a shrink wrapped package of 6, in the following configurations:
100 mL in glass vial (NDC 67684-2000-4)
DOTAREM Pharmacy Bulk Package is also packaged in a box of 6, in the following configurations:
100 mL in glass vial (NDC 67684-2001-4)
Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP, Controlled Room Temperature (CRT)].
Should solidification occur in the vial because of exposure to the cold, bring DOTAREM to room temperature before use. If allowed to stand at room temperature for a minimum of 90 minutes, DOTAREM should return to a clear, colorless to yellow solution. Before use, examine the product to assure that all solids are dissolved and that the container and closure have not been damaged. Discard the vial if solids persist.
- Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Instruct patients to inform their healthcare provider if they:
- have a history of kidney disease, or
- have recently received a GBCA.
GBCAs increase the risk for NSF among patients with impaired elimination of the drugs. To counsel patients at risk for NSF:
- Describe the clinical manifestations of NSF.
- Describe procedures to screen for the detection of renal impairment.
Instruct the patients to contact their physician if they develop signs or symptoms of NSF following DOTAREM administration, such as burning, itching, swelling, scaling, hardening and tightening of the skin; red or dark patches on the skin; stiffness in joints with trouble moving, bending or straightening the arms, hands, legs or feet; pain in the hip bones or ribs; or muscle weakness.
Inform patients that they may experience:
- Reactions along the venous injection site, such as mild and transient burning or pain or feeling of warmth or coldness at the injection site.
- Side effects of headache, nausea, abnormal taste and feeling hot.
- Pregnancy: Advise pregnant women of the potential risk of fetal exposure to gadoterate [see Use in Specific Populations (8.1)].
- Gadolinium Retention: Advise patients that gadolinium is retained for months or years in brain, bone, skin, and other organs in patients with normal renal function. The clinical consequences of retention are unknown. Retention depends on multiple factors and is greater following administration of linear GBCAs than following administration of macrocyclic GBCAs [see Warnings and Precautions (5.3)].
821 Alexander Road, Suite 204,
Princeton, New Jersey 08540
Vials manufactured by Recipharm, France and Liebel-Flarsheim Company, USA for Guerbet
DOTAREM® (doh TAH rem)
(gadoterate meglumine) Injection for intravenous use
| What is DOTAREM? |
| What is the most important information I should know about DOTAREM? |
|Do not receive DOTAREM if you have had a severe allergic reaction to DOTAREM.|
Before receiving DOTAREM, tell your healthcare provider about all your medical conditions, including if you:
|What are possible side effects of DOTAREM? |
General information about the safe and effective uses of DOTAREM. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your healthcare provider for information about DOTAREM that is written for health professionals.
What are the ingredients in DOTAREM?Active ingredient: gadoterate meglumineInactive ingredients: DOTA, water for injection Manufactured by: Catalent (glass pre-filled syringes), Liebel-Flarsheim Company LLC (plastic pre-filled syringes and vials) and Recipharm (vials) for GuerbetFor more information, go to www.guerbet-us.com or call 1-877-729-6679.
This Medication Guide has been approved by the U.S. Food and Drug Administration. Rev. 4/2019
|DOTAREM gadoterate meglumine injection|
|DOTAREM gadoterate meglumine injection|
|Labeler — Guerbet LLC (037876096)|
|Registrant — Guerbet LLC (037876096)|
|Recipharm Monts||777990813||manufacture (67684-2000), analysis (67684-2000), pack (67684-2000), label (67684-2000)|
|Simafex||381108273||api manufacture (67684-2000), api manufacture (67684-2001), analysis (67684-2000)|
|PCAS Finland O.y||369587311||api manufacture (67684-2000), api manufacture (67684-2001), analysis (67684-2000)|
|Liebel-Flarsheim Company LLC||109024984||manufacture (67684-2001), label (67684-2001)|
Revised: 04/2020 Guerbet LLC
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