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Lazanda

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Lazanda

Lazanda Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Lazanda (fentanyl) nasal spray is a narcotic pain medicine used to treat "breakthrough" cancer pain. Lazanda is taken together with other non-fentanyl narcotic pain medicine that is used around the clock. This medication is not for treating pain that is not cancer-related, such as pain from surgery, dental work, or migraine headaches. Lazanda nasal is available only under a special program called Lazanda REMS. You must be registered in the program and sign documents stating that you understand the risks and benefits of using this medication. Common side effects include nausea, vomiting, constipation, dizziness, drowsiness, tiredness, or white patches or sores inside your mouth or on your lips.

The starting dose of Lazanda is one 100 mcg spray (1 spray in one nostril). Lazanda may interact with other narcotics, sedatives, tranquilizers, sleeping pills, muscle relaxers, other medicines that can make you sleepy or slow your breathing, aprepitant, modafanil, pioglitazone, St. John's wort, antibiotics, phenobarbital or other barbiturates, antifungal medications, heart or blood pressure medications, HIV/AIDS medicines, seizure medications, or steroids. Tell your doctor all medications and supplements you use. It is unknown if Lazanda will harm a fetus. This drug may cause breathing problems, seizure, or addiction and withdrawal symptoms in a newborn if the mother takes the medication during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant while using this drug. Lazanda may also cause drowsiness, breathing problems, or addiction and withdrawal symptoms in a nursing infant. Do not breastfeed while you are taking Lazanda. Withdrawal symptoms may occur if you suddenly stop taking this medication.

Our Lazanda (fentanyl) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Lazanda in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using fentanyl and call your doctor at once if you have a serious side effect such as:

  • slow heart rate, weak or shallow breathing, sighing;
  • confusion, extreme fear, unusual thoughts or behavior; or
  • feeling like you might pass out.

Less serious side effects may include:

  • nausea, vomiting, constipation;
  • dizziness, drowsiness, tired feeling; or
  • white patches or sores inside your mouth or on your lips.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Lazanda (Fentanyl Nasal Spray) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Lazanda FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse event rates observed in the clinical trials of a drug product cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of Lazanda has been evaluated in a total of 523 opioid-tolerant patients with breakthrough cancer pain. The average duration of therapy in patients in the long-term study was 73 days, with 153 patients being treated for over 3 months. Patients continuing into the open-label extension period of the safety study have been treated for up to 26 months.

The most commonly observed adverse events seen with Lazanda are typical of opioid side effects, such as nausea, constipation, somnolence, and headache. Expect opioid side effects and manage them accordingly.

The clinical trials of Lazanda were designed to evaluate safety and efficacy in treating breakthrough cancer pain; all patients were also taking concomitant opioids, such as sustained-release morphine, sustained-release oxycodone, or transdermal fentanyl, for their persistent cancer pain. The adverse reaction data presented in Table 1 reflect the actual percentage of patients experiencing each adverse effect among patients who received Lazanda for breakthrough cancer pain along with a concomitant opioid for persistent cancer pain. There has been no attempt to correct for concomitant use of other opioids, duration of Lazanda therapy, or cancer-related symptoms. Adverse events are included regardless of causality or severity. Table 1 lists adverse reactions with an overall frequency of 5% or greater within the total population that occurred during titration by maximum dose received. The ability to assign Lazanda a dose-response relationship to these adverse events is limited by the titration schemes used in these studies.

Table 1: Adverse Reactions That Occurred During Titration at a Frequency of ≥ 5%

System Organ Class MeDRA preferred term, n (%) 100 mcg
(N=483)
200 mcg
(N=380)
400 mcg
(N=301)
800 mcg
(N=161)
Total
(N=516)
Gastrointestinal disorders
Nausea 19 (4) 6 (2) 6 (2) 5 (3) 35 (7)
Vomiting 14 (3) 10 (3) 9 (3) 1 (1) 33 (6)

Table 2 lists, by dose, adverse reactions with an overall frequency of ≥ 5% within the total population that occurred after a final titrated dose had been determined.

Table 2: Adverse Reactions That Occurred During Maintenance Treatment at a Frequency of ≥ 5%

System Organ Class MeDRA preferred term, n (%) 100 mcg
(N=61)
200 mcg
(N=68)
400 mcg
(N=109)
800 mcg
(N=108)
Total
(N=346)
Gastrointestinal disorders
Vomiting 8 (13) 5 (7) 9 (8) 12 (11) 34 (10)
Nausea 4 (7) 6 (9) 4 (4) 9 (8) 23 (7)
Constipation 6 (10) 1 (1) 8 (7) 5 (5) 20 (6)
General disorders and administration site conditions
Pyrexia 3 (5) 5 (7) 8 (7) 6 (6) 22 (6)

The adverse reactions listed below represent those that occurred in ≥ 1% of patients from clinical trials while receiving Lazanda. Events are classified by system organ class.

Adverse Events ( ≥ 1%)

Eye disorders: dry eye, swelling, ptosis, strabismus

Blood and Lymphatic System Disorders: anemia, neutropenia

Cardiac Disorders: cardiorespiratory arrest

Gastrointestinal Disorders: vomiting, nausea, constipation, diarrhea, abdominal pain, gastritis, ascites, dry mouth, dyspepsia, mouth ulcer, proctalgia

General Disorders and Administration Site Conditions: pyrexia, fatigue, edema peripheral, asthenia, edema

Hepatobiliary Disorders: jaundice

Immune System Disorders: hypersensitivity

Infections and Infestations: urinary tract infection, pneumonia, nasopharyngitis, infection, rhinitis, upper respiratory tract infection, bronchitis

Injury, Poisoning and Procedural Complications: fall

Investigations: weight decreased, blood alkaline phosphatase increased

Metabolism and Nutrition Disorders: dehydration, decreased appetite, hyperglycemia, anorexia

Musculoskeletal and Connective Tissue Disorders: back pain, pain in extremity, arthralgia

Nervous System Disorders: dizziness, somnolence, headache, dysgeusia

Psychiatric Disorders: anxiety, insomnia, depression, confusional state, disorientation, agitation Respiratory,

Thoracic and Mediastinal Disorders: dyspnea, epistaxis, cough, pharyngolaryngeal pain, nasal discomfort, rhinorrhea, nasal congestion, postnasal drip, pulmonary embolism

Skin and Subcutaneous Tissue Disorders: pruritus, hyperhidrosis, decubitus ulcer, mouth ulceration

Vascular Disorders: hypertension, deep vein thrombosis

Read the entire FDA prescribing information for Lazanda (Fentanyl Nasal Spray) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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