Applying and Wearing SANCUSO

Applying and Wearing SANCUSO

 

Before starting SANCUSO tell your healthcare professional about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Some of them may affect how SANCUSO works or how your other medicines work.

 

Follow these steps for proper application:

 

The SANCUSO transdermal system comes inside a pouch which is inside the carton. Each pouch contains one Sancuso patch

Remove the patch from the carton; tear the pouch open and remove the patch. Each pouch contains 1 SANCUSO patch stuck onto a rigid plastic film, and a separate clear protective liner.

    • Do not remove the SANCUSO patch from the pouch until you are ready to use it

    • Do not cut the SANCUSO patch into pieces

 

Remove the thin liner from the printed side of the patch

 

Remove the thin, clear protective liner to expose the printed side of the patch. Carefully bend the patch to remove the rigid lining

Bend the patch in the middle and remove one half of the rigid plastic film. Be careful not to stick the patch to itself and avoid touching the sticky side of the patch.

 

Firmly press the patch to the skin and smooth it down

 

While holding the remaining half of the rigid plastic film, apply the patch to the skin. Remove the second half of the rigid plastic film and press the whole patch firmly in place with your fingers and smooth down. Press firmly making sure it sticks well, especially around the edges.

Wash your hands right away after applying the patch to remove any medicine that might have stuck to your fingers.

 

The Sancuso patch can be worn up to 7 days, depending on how long your chemotherapy treatment lasts

Keep the patch in place for the duration of the chemotherapy. Remove the patch at least 1 day (24 hours) after chemotherapy is finished. The patch can be worn up to 7 days, depending on the number of days your chemotherapy treatment lasts.

 

Do not re-use the SANCUSO patch after you remove it. See instructions included with your SANCUSO patch on how to remove and throw away after use.

 

Wearing SANCUSO

 

Avoid sunlight. The medicine in SANCUSO may not work as well and/or may affect your skin if exposed to direct sunlight or the light from sunlamps or tanning beds. While you are wearing SANCUSO, you must keep it covered (ie, under clothing) if there is a risk of exposure to sunlight or sunlamps. Continue to keep the application area covered for 10 days after removing SANCUSO

Showering or bathing will not change the way that SANCUSO works—however, you should try to avoid immersing SANCUSO in water for long periods of time to prevent the patch from coming off

 

Because there is no information on the effect of swimming, strenuous exercise, or use of a sauna or whirlpool on the patch, you should also avoid these activities while wearing SANCUSO

 

When not to use SANCUSO

 

Avoid use if you are allergic to granisetron or any of the other ingredients in SANCUSO, or if you have allergies to medical adhesive tape, adhesive dressings, or other skin patches

 

Avoid use if you are pregnant or breastfeeding unless your healthcare professional has told you that you can use it. Be sure to tell your healthcare professional if you are pregnant, if you become pregnant, or plan to become pregnant while using SANCUSO, or if you are planning to breastfeed or are breastfeeding

 

Possible side effects of SANCUSO

 

SANCUSO can cause side effects in some patients. The most common side effects with SANCUSO are constipation and headache

 

Be sure to notify your healthcare professional if you have pain in your abdomen or your abdomen becomes swollen

 

While you are wearing SANCUSO, you may see some mild redness at or around the patch application site. If uncomfortable irritation or excessive itchiness occurs, remove the patch and call your healthcare professional

INDICATIONS AND USAGE

SANCUSO® (granisetron transdermal system) is indicated for the prevention of nausea and vomiting in adults receiving moderately and/or highly emetogenic chemotherapy regimens of up to 5 consecutive days.


CONTRADICTIONS

Sancuso is contraindicated in patients with known hypersensitivity to granisetron or to any of the components of the transdermal system.


WARNINGS AND PRECAUTIONS
  • Progressive Ileus and Gastric Distention: Sancuso may mask a progressive ileus and/or gastric distention. This should be particularly considered before use of Sancuso in patients who have had recent abdominal surgery. Monitor for decreased bowel activity, particularly in patients with risk factors for gastrointestinal obstruction.
  • Serotonin Syndrome: The development of serotonin syndrome has been reported with 5-HT3 receptor antagonists. Patients should be monitored for the emergence of serotonin syndrome, especially with concomitant use of Sancuso and other serotonergic drugs.
  • If symptoms of serotonin syndrome occur, discontinue Sancuso and initiate supportive treatment. Patients should be informed of the increased risk of serotonin syndrome, especially if Sancuso is used concomitantly with other serotonergic drugs. Skin Reactions: In clinical trials with Sancuso, application site reactions were reported that were generally mild in intensity and did not lead to discontinuation of use. The incidence of reactions was comparable with placebo. If severe reactions, or a generalized skin reaction occur (e.g., allergic rash, including erythematous, macular, papular rash or pruritus), remove the Sancuso transdermal system.
  • Increased Drug Exposure with Use of External Heat Sources: Prolonged exposure to heat results in increasing plasma concentrations of granisetron during the period of heat exposure. Do not apply a heat pad or heat lamp over or in the vicinity of the Sancuso transdermal system and avoid extended exposure to heat.
  • Phototoxicity with Ultraviolet Light Exposure: Granisetron may be affected by direct natural or artificial sunlight, including sunlamps. An in vitro study using Chinese hamster ovary cells suggests that granisetron has the potential for photogenotoxicity. To avoid a potential skin reaction, advise patients to cover the application site of the transdermal system with clothing if there is a risk of exposure to direct natural or artificial sunlight throughout the period of wear and for 10 days following its removal.

Adverse Reactions

The most common adverse reaction (≥ 3%) is constipation.

You are encouraged to report suspected adverse reactions to Cumberland Pharmaceuticals Inc. at 1-800-Sancuso or FDA at 1-800-FDA-1088 or www.fda.gov/ medwatch.

See full Prescribing Information for SANCUSO.