Herceptin Lyophilisate For Solution For Injection 440Mg Drug Medication Dosage Information
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Herceptin: Lyophilisate for solution for injection (440mg)

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What is this Medicine?

TRASTUZUMAB (tras TOO zoo mab) is a monoclonal antibody. It is used to treat breast cancer and stomach cancer.

In-Depth Information

Herceptin 440mg Powder for Injection

NDC: 502420134
  • Prescription Required
  • Not a Controlled Drug
    (CSA Schedule)
  • FDA Approved




FDA approved for the following conditions:
Breast Cancer, Gastric Cancer

Storage Information
Store unreconstituted product in refrigerator (36 to 46 degrees F)
Store reconstituted product diluted in NaCl at 36 to 46 degrees F for no more than 24 hours prior to use
Do not freeze reconstituted product
Product reconstituted with BWFI is stable for 28 days when stored under refrigeration (36 to 46 degrees F)
Product reconstituted with SWFI should be used immediately and any used portion discarded
Herceptin 440mg Powder for Injection

Reported Side Effects for Herceptin 440mg Powder for Injection

Antibody Formation Incidence:
0.1%*
Severity: MODERATE
Onset: DELAYED
Heart Attack Incidence:
0.2-0.3%*
Severity: SEVERE
Onset: DELAYED
High Pressure In Lungs Incidence:
0.2%*
Severity: SEVERE
Onset: DELAYED
Lung Inflammation Incidence:
0.2-0.7%*
Severity: MODERATE
Onset: DELAYED
Heart Failure Incidence:
0.4-28.0%*
Severity: SEVERE
Onset: DELAYED
Nerve Pain Incidence:
1.0-13.0%*
Severity: MODERATE
Onset: DELAYED
Infusion-related Reactions Incidence:
1.4-9.0%*
Severity: SEVERE
Onset: RAPID
Flu Incidence:
2.0-12.0%*
Severity: MILD
Onset: DELAYED
Stomach Pain Incidence:
2.0-34.0%*
Severity: MILD
Onset: EARLY
Sinus Infection Incidence:
2.0-21.0%*
Severity: MILD
Onset: DELAYED
Rhinitis Incidence:
2.0-22.0%*
Severity: MILD
Onset: EARLY
Itching Incidence:
2.0%*
Severity: MILD
Onset: RAPID
Constipation Incidence:
2.0%*
Severity: MODERATE
Onset: DELAYED
Acne Incidence:
2.0-11.0%*
Severity: MILD
Onset: DELAYED
Inflamed Nerve Incidence:
2.0-23.0%*
Severity: MODERATE
Onset: DELAYED
Upset Stomach Incidence:
2.0%*
Severity: MILD
Onset: EARLY
Nose Bleed Incidence:
2.0%*
Severity: MILD
Onset: DELAYED
Blood Clot Incidence:
2.1-3.0%*
Severity: SEVERE
Onset: DELAYED
Shortness Of Breath Incidence:
2.5-42.0%*
Severity: MODERATE
Onset: EARLY
Kidney Failure Incidence:
2.7%*
Severity: SEVERE
Onset: DELAYED
Low White Blood Cell Counts Incidence:
3.0-52.0%*
Severity: MODERATE
Onset: DELAYED
Bone Pain Incidence:
3.0-24.0%*
Severity: MODERATE
Onset: DELAYED
Abnormal Heart Rhythm Incidence:
3.0%*
Severity: SEVERE
Onset: EARLY
Rapid Heart Rate Incidence:
3.0%*
Severity: MODERATE
Onset: EARLY
Vomiting Incidence:
3.5-53.0%*
Severity: MILD
Onset: EARLY
Inability To Sleep Incidence:
3.7-29.0%*
Severity: MILD
Onset: EARLY
Skin Rash Incidence:
4.0-38.0%*
Severity: MILD
Onset: EARLY
Anemia Incidence:
4.0-36.0%*
Severity: MODERATE
Onset: DELAYED
High Blood Pressure Incidence:
4.0%*
Severity: MODERATE
Onset: EARLY
Lightheadedness Incidence:
4.0-24.0%*
Severity: MILD
Onset: EARLY
Muscle Pain Incidence:
4.0-10.0%*
Severity: MILD
Onset: EARLY
Weakness Incidence:
4.5-62.0%*
Severity: MILD
Onset: DELAYED
Cough Incidence:
5.0-43.0%*
Severity: MILD
Onset: DELAYED
Back Pain Incidence:
5.0-34.0%*
Severity: MILD
Onset: DELAYED
Chills Incidence:
5.0-41.0%*
Severity: MILD
Onset: RAPID
Fluid Retention Incidence:
5.0-22.0%*
Severity: MODERATE
Onset: DELAYED
Rapid Heart Rate Incidence:
5.0-12.0%*
Severity: MODERATE
Onset: RAPID
Joint Pain Incidence:
6.0-37.0%*
Severity: MILD
Onset: DELAYED
Upset Stomach Incidence:
6.0-76.0%*
Severity: MILD
Onset: EARLY
Sore Throat Incidence:
6.0-30.0%*
Severity: MILD
Onset: DELAYED
Headache Incidence:
6.0-44.0%*
Severity: MILD
Onset: EARLY
Fever Incidence:
6.0-56.0%*
Severity: MILD
Onset: EARLY
Difficulty Swallowing Incidence:
6.0%*
Severity: MODERATE
Onset: DELAYED
Depression Incidence:
6.0-20.0%*
Severity: MODERATE
Onset: DELAYED
Loose Stools Incidence:
7.0-45.0%*
Severity: MILD
Onset: EARLY
Low White Blood Cells Incidence:
7.1-36.8%*
Severity: MODERATE
Onset: DELAYED
Swelling Incidence:
8.0-11.0%*
Severity: MODERATE
Onset: DELAYED
Paresthesias Incidence:
9.0-48.0%*
Severity: MILD
Onset: DELAYED
Metallic Taste Incidence:
10.0%*
Severity: MILD
Onset: EARLY
Decreased Appetite Incidence:
14.0-31.0%*
Severity: MILD
Onset: DELAYED
Low Platelet Count Incidence:
16.0%*
Severity: MODERATE
Onset: DELAYED
Hot Flashes Incidence:
17.0%*
Severity: MODERATE
Onset: EARLY
Infection Incidence:
20.0-47.0%*
Severity: MILD
Onset: DELAYED
Weight Loss Incidence:
23.0%*
Severity: MILD
Onset: DELAYED
Mouth Ulcers Incidence:
24.0%*
Severity: MODERATE
Onset: DELAYED
Tired Incidence:
28.0-35.0%*
Severity: MILD
Onset: EARLY
*This is an approximate aggregated range of reported side effects from clinical studies performed on this drug. Your experience with this drug may be different.
Pregnancy & Lactation Information
FIRST Trimester

Class D - Adequate well-controlled or observational studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential risk. For example, the drug may be acceptable if needed in a life-threatening situation or serious disease for which safer drugs cannot be used or are ineffective.

SECOND Trimester

Class D - Adequate well-controlled or observational studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential risk. For example, the drug may be acceptable if needed in a life-threatening situation or serious disease for which safer drugs cannot be used or are ineffective.

THIRD Trimester

Class D - Adequate well-controlled or observational studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential risk. For example, the drug may be acceptable if needed in a life-threatening situation or serious disease for which safer drugs cannot be used or are ineffective.

Lactation

Avoid - This drug is known to cause harm to infants when taken by nursing mothers.


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