Lazanda
- Generic Name: fentanyl nasal spray
- Brand Name: Lazanda
- Drug Class: Opioid Analgesics
Lazanda (Fentanyl Nasal Spray) side effects drug center
Lazanda Side Effects Center
What Is Lazanda?
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. Lazanda is not for treating pain that is not cancer-related, such as pain from surgery, dental work, or migraine headaches. Lazanda nasal spray 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 Lazanda.
What Are Side Effects of Lazanda?
Common side effects of Lazanda include:
- nausea,
- vomiting,
- constipation,
- dizziness,
- drowsiness,
- tiredness, or
- white patches or sores inside your mouth or on your lips.
Tell your doctor if you have serious side effects of Lazanda including:
- slow heart rate,
- weak or shallow breathing,
- sighing,
- confusion,
- extreme fear,
- unusual thoughts or behavior, or
- feeling like you might pass out.
Dosage for Lazanda
The starting dose of Lazanda is one 100 mcg spray (1 spray in one nostril).
What Drugs, Substances, or Supplements Interact with Lazanda?
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.
Lazanda During Pregnancy and Breastfeeding
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.
Additional Information
Our Lazanda (fentanyl) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Lazanda Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.
Call your doctor at once if you have:
- slow heart rate, sighing, shallow breathing, breathing that stops during sleep;
- confusion, extreme fear, unusual thoughts or behavior;
- dizziness, feeling like you might pass out; or
- worsening tiredness or weakness.
Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.
Serious side effects may be more likely in older adults and those who are malnourished or debilitated.
Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.
Common side effects may include:
- dizziness, drowsiness, weakness;
- anxiety, depression;
- trouble sleeping;
- stomach pain, nausea, vomiting, constipation; or
- swelling in your arms, hands, legs or feet.
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)
Lazanda Professional Information
SIDE EFFECTS
The following serious adverse reactions are described, or described in greater detail, in other sections:
- Life-Threatening Respiratory Depression [see WARNINGS AND PRECAUTIONS]
- Interactions with benzodiazepines and other CNS Depressants [see WARNINGS AND PRECAUTIONS
- Addiction, Abuse, and Misuse [see WARNINGS AND PRECAUTIONS]
- Neonatal Opioid Withdrawal Syndrome [see WARNINGS AND PRECAUTIONS]
- Serotonin Syndrome [see WARNINGS AND PRECAUTIONS]
- Adrenal Insufficiency [see WARNINGS AND PRECAUTIONS]
- Severe Hypotension [see WARNINGS AND PRECAUTIONS]
- Gastrointestinal Adverse Reactions [see WARNINGS AND PRECAUTIONS]
- Seizures [see WARNINGS AND PRECAUTIONS]
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 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 cancerrelated 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 MedDRA 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) |
| Nervous system disorders | |||||
| Dizziness | 14 (3) | 11 (3) | 6 (2) | 4 (2) | 31 (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 MedDRA 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.
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
Postmarketing Experience
The following adverse reactions have been identified during post approval use fentanyl. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Serotonin syndrome: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.
Adrenal insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.
Anaphylaxis: Anaphylaxis has been reported with ingredients contained in LAZANDA.
Androgen deficiency: Cases of androgen deficiency have occurred with chronic use of opioids [see CLINICAL PHARMACOLOGY].
Read the entire FDA prescribing information for Lazanda (Fentanyl Nasal Spray)
&Copy; Lazanda Patient Information is supplied by Cerner Multum, Inc. and Lazanda Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.