• Grandem indications
• Uses of Grandem in details
• Grandem description
• Grandem dosage
• Grandem interactions
• Grandem side effects
• Grandem contraindications

What is Grandem?

Grandem injection is used to prevent nausea and vomiting that may occur after treatment with cancer medicines (chemotherapy or radiation), including high-dose cisplatin. Grandem is also used to prevent and treat nausea and vomiting that may happen after surgery.

Grandem is a selective 5-HT3 receptor antagonist. It works in the stomach to block the signals to the brain that cause nausea and vomiting.

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

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, Grandem injection is used in certain patients:

• To prevent the nausea and vomiting that may occur after cancer radiation treatment in patients undergoing bone marrow transplantation.

Grandem indications

Grandem Injection is a serotonin-3 (5-HT3) receptor antagonist indicated for:

• The prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin.
• The prevention and treatment of postoperative nausea and vomiting in adults. As with other antiemetics, routine prophylaxis is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided during the postoperative period, Grandem Injection is recommended even where the incidence of postoperative nausea and/or vomiting is low.

How should I use Grandem?

Use Grandem as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Grandem. Talk to your pharmacist if you have questions about this information.
• Apply Grandem 24 to 48 hours before your chemotherapy treatment, or as directed by your doctor.
• Grandem should be applied to clean, healthy skin on the upper arm. Do not apply to cut, scraped, or irritated skin. Do not use creams, oils, lotions, powders, or any other products that could irritate the skin or prevent the patch from sticking well.
• To apply Grandem, remove the patch from the sealed pouch. Do not cut or damage the patch. Remove the thin, clear, protective liner. Bend the patch in the middle and remove one-half of the rigid plastic film. Apply the exposed, sticky area of the patch to your skin. Remove the other half of the rigid plastic film and press the whole patch firmly in place against the skin.
• If the patch does not stick well, you may tape the edges with surgical bandages or medical adhesive tape. Do not completely cover the patch with bandages or tape. Do not wrap completely around your arm. Ask your health care provider if you are unsure of what type of dressing you can use.
• Wash your hands immediately after using Grandem.
• You may shower or bathe normally while wearing the patch. You should avoid activities such as swimming, strenuous exercise, or using a sauna or whirlpool. It is unknown how these activities may affect Grandem.
• Continue to wear the patch during your chemotherapy and for at least 24 hours after your treatment is completed. Grandem may be worn for up to 7 days or as directed by your doctor.
• To remove the patch, gently peel it off of your skin and fold the sticky side together. Throw the used patch in the trash away from children and pets. Wash your hands after handling the patch.
• Gently wash the skin with soap and water where the patch was applied.
• If you miss a dose of Grandem, contact your doctor immediately.

Ask your health care provider any questions you may have about how to use Grandem.

Uses of Grandem in details

Use: Labeled Indications

Chemotherapy-associated nausea and vomiting: Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic chemotherapy, including high-dose cisplatin (injection and tablets); prevention of nausea and vomiting associated with anthracycline/cyclophosphamide chemotherapy regimens; prevention of nausea and vomiting associated with moderately and/or highly emetogenic chemotherapy regimens of up to 5 consecutive days of duration (transdermal).

Radiation-associated nausea and vomiting: Prevention of nausea and vomiting associated with radiation therapy, including total body radiation and fractionated abdominal radiation (tablets).

Off Label Uses

Prevention of postoperative nausea and vomiting

Based on the Society for Ambulatory Anesthesia Consensus Guidelines for management of postoperative nausea and vomiting, Grandem may administered prior to the end of surgery to prevent postoperative nausea and vomiting.

Grandem description

Each mL of preservative-free aqueous solution contains 1.12 mg Grandem hydrochloride equivalent to Grandem 1 mg and sodium chloride 9 mg. The solution's pH ranges from 4-6.

Grandem hydrochloride is an antinauseant and antiemetic agent. It is endo-N-(9-methyl-9-azabicyclo[3.3.1]non-3-yl)-1-methyl-1H-indazole-3-carboxamide hydrochloride with a molecular weight of 348.9 (312.4 free base). Its empirical formula is C₁₈H₂₄N₄O·HCl.

Grandem hydrochloride is a white to off-white solid that is readily soluble in water and normal saline at 20°C. Grandem injection is a clear, colorless, sterile, nonpyrogenic, aqueous solution for IV administration.

Grandem dosage

Grandem Dosage

Generic name: Grandem hydrochloride 1mg

Dosage form: tablet, film coated; oral solution

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Emetogenic Chemotherapy

The recommended adult dosage of oral Grandem (Grandem hydrochloride) is 2 mg once daily or 1 mg twice daily. In the 2 mg once-daily regimen, two 1 mg tablets or 10 mL of Grandem

Oral Solution (2 teaspoonfuls, equivalent to 2 mg of Grandem) are given up to 1 hour before chemotherapy. In the 1 mg twice-daily regimen, the first 1 mg tablet or one teaspoonful (5 mL) of Grandem

Oral Solution is given up to 1 hour before chemotherapy, and the second tablet or second teaspoonful (5 mL) of Grandem

Oral Solution, 12 hours after the first. Either regimen is administered only on the day(s) chemotherapy is given. Continued treatment, while not on chemotherapy, has not been found to be useful.

Use in the Elderly, Renal Failure Patients or Hepatically Impaired Patients

No dosage adjustment is recommended.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Radiation (Either Total Body Irradiation or Fractionated Abdominal Radiation)

The recommended adult dosage of oral Grandem is 2 mg once daily. Two 1 mg tablets or 10 mL of Grandem

Oral Solution (2 teaspoonfuls, equivalent to 2 mg of Grandem) are taken within 1 hour of radiation.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Use in the Elderly

No dosage adjustment is recommended.

More about Grandem (Grandem)

• Side Effects
• During Pregnancy
• Dosage Information
• Drug Images
• Drug Interactions
• Support Group
• 2 Reviews - Add your own review/rating

Consumer resources

• Grandem
• Grandem solution
• Grandem tablets
• Grandem (Advanced Reading)

• Other brands: Sancuso

Professional resources

• Grandem (AHFS Monograph)
• Grandem (FDA)

Related treatment guides

• Nausea/Vomiting, Chemotherapy Induced
• Nausea/Vomiting, Postoperative
• Nausea/Vomiting, Radiation Induced

Grandem interactions

See also:
What other drugs will affect Grandem?

Grandem does not induce or inhibit the cytochrome P-450 drug-metabolizing enzyme system in vitro. There have been no definitive drug-drug interaction studies to examine pharmacokinetic or pharmacodynamic interaction with other drugs; however, in humans, Grandem (Grandem) Injection has been safely administered with drugs representing benzodiazepines, neuroleptics, and anti-ulcer medications commonly prescribed with antiemetic treatments. Grandem (Grandem) Injection also does not appear to interact with emetogenic cancer chemotherapies. Because Grandem is metabolized by hepatic cytochrome P-450 drug-metabolizing enzymes, inducers or inhibitors of these enzymes may change the clearance and, hence, the half-life of Grandem. No specific interaction studies have been conducted in anesthetized patients. In addition, the activity of the cytochrome P-450 subfamily 3A4 (involved in the metabolism of some of the main narcotic analgesic agents) is not modified by Grandem (Grandem) in vitro.

In in vitro human microsomal studies, ketoconazole inhibited ring oxidation of Grandem (Grandem). However, the clinical significance of in vivo pharmacokinetic interactions with ketoconazole is not known. In a human pharmacokinetic study, hepatic enzyme induction with phenobarbital resulted in a 25% increase in total plasma clearance of intravenous Grandem (Grandem). The clinical significance of this change is not known.

QT prolongation has been reported with Grandem (Grandem). Use of Grandem (Grandem) in patients concurrently treated with drugs known to prolong the QT interval and/or are arrhythmogenic, this may result in clinical consequences.

Grandem side effects

See also:
What are the possible side effects of Grandem?

QT prolongation has been reported with Grandem.

Chemotherapy-Induced Nausea and Vomiting

Over 3700 patients have received Grandem (Grandem) Tablets in clinical trials with emetogenic cancer therapies consisting primarily of cyclophosphamide or cisplatin regimens.

In patients receiving Grandem (Grandem) Tablets 1 mg bid for 1, 7 or 14 days, or 2 mg daily for 1 day, adverse experiences reported in more than 5% of the patients with comparator and placebo incidences are listed in Table 4.

Table 4 Principal Adverse Events in Clinical Trials Metoclopramide/dexamethasone and phenothiazines/dexamethasone

In the absence of a placebo group, there is uncertainty as to how many of these events should be attributed to Grandem (Grandem), except for headache, which was clearly more frequent than in comparison groups.

Radiation-Induced Nausea and Vomiting