Zelapar Side Effects Center

Last updated on RxList: 10/15/2021
Zelapar Side Effects Center

What Is Zelapar?

Zelapar (selegiline hydrochloride) is an enzyme blocker (MAO inhibitor) that works by slowing the breakdown of certain natural substances in the brain (neurotransmitters such as dopamine, norepinephrine, and serotonin) used together with other medicines to treat symptoms of Parkinson's disease.

What Are Side Effects of Zelapar?

Common side effects of Zelapar include:

Tell your doctor if you have serious side effects of Zelapar including:

Dosage for Zelapar

Treatment with Zelapar should be initiated with a 1.25 mg dose given once a day for at least 6 weeks. After 6 weeks, the dose may be escalated to 2.5 mg given once a day if prescribed.

What Drugs, Substances, or Supplements Interact with Zelapar?

Zelapar may interact with arbamazepine, diet pills or cold medicines that contain ephedrine, pseudoephedrine, or phenylephrine, nafcillin, phenobarbital, rifampin, or antidepressants. Many other medicines can cause serious medical problems if taken together with Zelapar. Tell your doctor all medications and supplements you use.

Zelapar During Pregnancy and Breastfeeding

During pregnancy, Zelapar should be used only when prescribed. It is unknown if this drug passes into breast milk, but it may have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.

Additional Information

Our Zelapar (selegiline hydrochloride) 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.

QUESTION

Parkinson's disease is only seen in people of advanced age. See Answer
Zelapar Consumer Information

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

Call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;
  • trouble breathing;
  • confusion, hallucinations, unusual thoughts or behavior;
  • increased tremors or uncontrolled muscle movements;
  • worsening side effects of your other medications;
  • high levels of serotonin in the body (when taken with an antidepressant)--agitation, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting; or
  • dangerously high blood pressure--severe headache, blurred vision, pounding in your neck or ears, anxiety, nausea, vomiting, severe chest pain, shortness of breath, pounding heartbeats, or seizure (convulsions).

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medicine. Talk with your doctor if this occurs.

Common side effects may include:

  • dizziness;
  • nausea, stomach pain, constipation;
  • skin rash or other irritation;
  • sleep problems (insomnia); or
  • mouth sores or ulcers, pain with swallowing (while using selegiline orally disintegrating tablets).

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.

SLIDESHOW

Dementia, Alzheimer's Disease, and Aging Brains See Slideshow
Zelapar Professional Information

SIDE EFFECTS

PI: Intravenous: The serious adverse reaction seen during intravenous treatment in the clinical studies for PI was aseptic meningitis. The most common adverse reactions for PI (observed in ≥5% of subjects) were headache, fatigue, pyrexia, nausea, chills, rigors, pain in extremity, diarrhea, migraine, dizziness, vomiting, cough, urticaria, asthma, pharyngolaryngeal pain, rash, arthralgia, myalgia, oedema peripheral, pruritus, and cardiac murmur.

Subcutaneous: No serious adverse reactions were observed during the clinical study of subcutaneous treatment. The most common adverse reactions during subcutaneous treatment (observed in ≥5% of PI subjects) were infusion site (local) event, headache, fatigue, heart rate increased, pyrexia, abdominal pain upper, nausea, vomiting, asthma, blood pressure systolic increased, diarrhea, ear pain, aphthous stomatitis, migraine, oropharyngeal pain, and pain in extremity.

MMN: The serious adverse reactions in the clinical study for MMN were pulmonary embolism and blurred vision. The most common adverse reactions for MMN (observed in ≥5% of subjects) were headache, chest discomfort, muscle spasms, muscular weakness, nausea, oropharyngeal pain, and pain in extremity.

Clinical Trials Experience

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

PI: Intravenous Administration

The safety of GAMMAGARD LIQUID intravenous infusion was evaluated in 61 subjects.

Fifteen adverse reactions in 8 subjects were serious. Of these, two episodes of aseptic meningitis in one subject were deemed possibly related to infusion of GAMMAGARD LIQUID.

There were 400 non-serious adverse reactions. Of these, 217 were rated as mild (transient discomfort that resolves spontaneously or with minimal intervention), 164 were rated as moderate (limited impairment of function and resolves spontaneously or with minimal intervention with no sequelae), and 19 were rated as severe (marked impairment of function or can lead to temporary inability to resume normal life pattern; requires prolonged intervention or results in sequelae). All of the severe non-serious adverse experiences were transient, did not lead to hospitalization, and resolved without complication. One subject withdrew from the study due to a non-serious adverse experience (papular rash).

Adverse reactions with a frequency of ≥5% (defined as adverse events occurring during or within 72 hours of infusion or any causally related event occurring within the study period) are shown in Table 5.

Table 5 : Adverse Reactions Occurring in ≥5% of Subjects

Events By Infusion N (%)
(N=1812 Infusions)
By Subject N (%)
(N=61 Subjects)
Headache 94 (5.2%) 29 (47.5%)
Fatigue 33 (1.8%) 14 (23.0%)
Pyrexia 28(1.5%) 17 (27.9%)
Nausea 17 (0.9%) 11 (18.0%)
Chills 14 (0.8%) 8(13.1%)
Rigors 14 (0.8%) 8(13.1%)
Pain in extremity 13 (0.7%) 7 (11.5%)
Diarrhea 12 (0.7%) 9(14.8%)
Migraine 12 (0.7%) 4 (6.6%)
Dizziness 11 (0.6%) 8(13.1%)
Vomiting 11 (0.6%) 9(14.8%)
Cough 9 (0.5%) 8(13.1%)
Urticaria 9 (0.5%) 5 (8.2%)
Asthma 7 (0.4%) 6 (9.8%)
Pharyngolaryngeal pain 7 (0.4%) 5 (8.2%)
Rash 6 (0.3%) 4 (6.6%)
Arthralgia 5 (0.3%) 4 (6.6%)
Myalgia 5 (0.3%) 5 (8.2%)
Oedema peripheral 5 (0.3%) 5 (8.2%)
Pruritus 5 (0.3%) 4 (6.6%)
Cardiac murmur 4 (0.2%) 4 (6.6%)

Pooled analysis of 4 short term clinical studies with 106 subjects (total of 854 infusions) showed no differences in the safety profile of GAMMAGARD LIQUID. These short term studies were designed to stabilize the immune globulin treatment or as a safety follow-up study. They were not designed to study the safety, efficacy and tolerability of GAMMAGARD LIQUID. No additional adverse reactions were reported during the study periods.

PI: Subcutaneous Administration

The safety of GAMMAGARD LIQUID in subcutaneous infusion was evaluated in 47 subjects.

Adverse reactions with a frequency of ≥5% (defined as adverse events occurring during or within 72 hours of infusion or any causally related event occurring within the study period) are shown in Table 6.

Table 6 : Adverse Reactions Occurring in ≥5% of Subjects

Events By Infusion N (%)
(N=2294 infusions)
By Subject N (%)
(N=47 Subjects)
Infusion site (local) event 55 (2.4%) 21 (44.7%)
Headache 31 (1.4%) 19 (40.4%)
Fatigue 11 (0.5%) 7(14.9%)
Heart rate increased 11 (0.5%) 3 (6.4%)
Pyrexia 11 (0.5%) 9(19.1%)
Abdominal pain upper 9 (0.4%) 5 (10.6%)
Nausea 7 (0.3%) 3 (6.4%)
Vomiting 7 (0.3%) 5 (10.6%)
Asthma 6 (0.3%) 4 (8.5%)
Blood pressure systolic increased 6 (0.3%) 3 (6.4%)
Diarrhea 5 (0.2%) 3 (6.4%)
Ear pain 4 (0.2%) 3 (6.4%)
Aphthous stomatitis 3 (0.1%) 3 (6.4%)
Migraine 3 (0.1%) 3 (6.4%)
Oropharyngeal pain 3 (0.1%) 3 (6.4%)
Pain in extremity 3 (0.1%) 3 (6.4%)

Of the 348 non-serious adverse reactions, 228 were rated as mild (transient discomfort that resolves spontaneously or with minimal intervention), 112 were rated as moderate (limited impairment of function and resolves spontaneously or with minimal intervention with no sequelae), and 8 were rated as severe (marked impairment of function or can lead to temporary inability to resume normal life pattern; requires prolonged intervention or results in sequelae). Neither of the severe adverse reactions required hospitalization or resulted in sequelae.

Local Adverse Reactions

Local adverse reactions reported as mild (transient discomfort that resolves spontaneously or with minimal intervention) were rash, erythema, edema, hemorrhage, and irritation. Local adverse reactions reported as mild or moderate (limited impairment of function and resolves spontaneously or with minimal intervention with no sequelae) were pain, hematoma, pruritus, and swelling.

One subject withdrew from the study after 10 treatments with GAMMAGARD LIQUID subcutaneous infusion (2.5 months) due to increased fatigue and malaise.

The overall rate of local adverse reactions (excluding infections) during subcutaneous treatment was 2.4% per infusion. In subcutaneous naive subjects, the incidence of local adverse reactions (N=1757 infusions) was 2.8% (2.2% mild and 0.6% moderate with no severe adverse reactions). In the subjects who were subcutaneous experienced (N=537 infusions), the incidence of local adverse reactions was 1.1% (1.1% mild, and no moderate or severe adverse reactions).

After all subcutaneous doses were adjusted, only one subject did not reach the maximum rate allowed in the protocol for one or more infusions, 20 mL/site/hour if weight was below 40 kg and 30/mL/hour for weight 40 kg and greater. Overall, 70% (31 of 44) of subjects opted for the highest rate for all infusions. No subject limited the infusion rate due to an adverse reaction. Median duration of each weekly infusion was 1.2 hours (range: 0.8-2.3 hours). The rate set on the pump was the rate per site multiplied by the number of sites, with no maximum.

During subcutaneous treatment, 99.8% of infusions were completed without a reduction, interruption, or discontinuation for tolerability reasons. The proportion of subjects who experienced local adverse reactions (excluding infections) was highest immediately following the switch from intravenous to subcutaneous treatment in all age groups. The rate of local adverse reactions per infusion immediately after switching from intravenous to subcutaneous treatment was 4.9% (29/595), decreasing to 1.5% (8/538) by the end of the study and to 1.1% (10/893) in the Study Extension. There was a decrease of local adverse reactions over subsequent subcutaneous infusions.

Eight (17%) subjects experienced a local adverse reaction during the first infusion, but that decreased to 1 (2.2%) for subsequent infusions, ranging from 0 to 4 (8.7%) during the first year of subcutaneous treatment. No subject reported a local adverse reaction from week 53 to end of study at week 68.

Analysis of a short term follow-up safety study of 10 subjects who were treated with subcutaneous administration of GAMMAGARD LIQUID (total of 218 infusions) showed no differences in the safety profile. The follow-up safety study was not designed to study the safety, efficacy and tolerability of GAMMAGARD LIQUID and no additional adverse reactions were reported during the study period.

MMN: Intravenous Infusion

The safety of GAMMAGARD LIQUID was evaluated in 44 subjects with MMN who received a total of 983 infusions. Two serious adverse reactions, pulmonary embolism and blurred vision, occurred.

In the study, among the 317 non-serious adverse reactions, 176 were considered ARs. Of these, 126 were mild (transient discomfort that resolves spontaneously or with minimal intervention), 37 were moderate (limited impairment of function and resolves spontaneously or with minimal intervention with no sequelae) and 13 were severe (marked impairment of function or can lead to temporary inability to resume normal life pattern; requires prolonged intervention or results in sequelae).

Adverse reactions with a frequency ≥5% (defined as adverse events occurring during or within 72 hours of infusion or any causally related event occurring within the study period) are shown in Table 7.

Table 7 : Adverse Reactions Occurring in ≥5% of MMN Subjects

Events GAMMAGARD LIQUID Placebo
By Infusion
N (%) (N=983 Infusions)
By Subject
N (%) (N=44 Subjects)
By Infusion
N (%) (N=129 Infusions)
By Subject
N (%) (N=43 Subjects)
Headache 28 (2.85%) 14 (31.82%) 3 (2.33%) 2 (4.65%)
Chest Discomfort 3 (0.31%) 3 (6.82%) 0 (0.00%) 0 (0.00%)
Muscle Spasms 3 (0.31%) 3 (6.82%) 0 (0.00%) 0 (0.00%)
Muscular weakness 4(0.41%) 3 (6.82%) 1 (0.78%) 1 (2.33%)
Nausea 28 (2.85%) 3 (6.82%) 2(1.55%) 1 (2.33%)
Oropharyngeal pain 4(0.41%) 3 (6.82%) 0 (0.00%) 0 (0.00%)
Pain in extremity 4(0.41%) 3 (6.82%) 1 (0.78%) 1 (2.33%)

Postmarketing Experience

Because postmarketing reporting of adverse reactions is voluntary and from a population of uncertain size, it is not always possible to reliably estimate the frequency of these reactions or establish a causal relationship to product exposure.

Intravenous Adverse Reactions

Blood and Lymphatic System Disorders : Hemolysis

Immune System Disorders : Anaphylactic shock

Nervous System Disorders : Cerebral vascular accident, transient ischemic attack, tremor

Cardiac Disorders : Myocardial infarction

Vascular Disorders : Deep vein thrombosis, hypotension

Respiratory, Thoracic and Mediastinal Disorders : Pulmonary embolism, pulmonary edema

Skin and Subcutaneous Tissue Disorders : Hyperhidrosis

General Disorders and Administration-Site Conditions : Chest pain

Investigations : Coombs direct test positive, oxygen saturation decreased

Injury, Poisoning and Procedural Complications : Transfusion-related acute lung injury

Subcutaneous Adverse Reactions

Immune System Disorders : Hypersensitive

Musculoskeletal and Connective Tissue Disorders : Myalgia

General Disorders and Administration-Site Conditions : Chills

In addition to the adverse reactions listed above, the following reactions have been identified for immune globulin products administered intravenously:

Renal and Urinary Disorders : Osmotic nephropathy

Respiratory, Thoracic and Mediastinal Disorders : Cyanosis, hypoxemia, bronchospasm, apnea, Acute Respiratory Distress Syndrome (ARDS)

Integumentary : Bullous dermatitis, epidermolysis, erythema multiforme, Stevens-Johnson Syndrome

Vascular Disorders : Cardiac arrest, vascular collapse

Nervous System Disorders : Coma, seizures, loss of consciousness

Blood and Lymphatic System Disorders : Pancytopenia

Gastrointestinal : Hepatic dysfunction

The adverse reactions listed below have been identified and reported with the use of another immune globlin products administered subcutaneously:

Immune System Disorders : Anaphylactic reaction

Nervous System Disorders : Paresthesia, tremor

Cardiac Disorders : Tachycardia

Vascular Disorders : Hypotension

Respiratory, Thoracic and Mediastinal Disorders : Dyspnea, laryngospasm

General Disorders and Administration-Site Conditions : Chest discomfort, injection site reaction (including induration, warmth)

DRUG INTERACTIONS

Passive transfer of antibodies may transiently impair the immune response to live attenuated virus vaccines such as mumps, rubella and varicella for up to 6 months, and for a year or more to measles (rubeola). Inform the immunizing physician of recent therapy with GAMMAGARD LIQUID so that appropriate precautions can be taken [see Patient Counseling Information].

Read the entire FDA prescribing information for Zelapar (Selegiline Hydrochloride)

© Zelapar Patient Information is supplied by Cerner Multum, Inc. and Zelapar Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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